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ROLL, PIN-FEED, SHEET-FEED LABELS

The GMP Labeling System


Founded in 1987, GMP Labeling serves companies that are regulated by the FDA and/or are registered
for ISO 9000 standards. Today the GMP Labeling System is used daily in more than 5000 facilities in the
U.S., Canada and Europe.
The GMP Labeling System offers labels, signs and software that make it easier to comply with GMP
regulations and ISO 9000 requirements as well as demonstrating commitment to compliance. GMP
Labeling products help you identify components, pilot batches, raw materials, in-process materials, and
areas in your laboratory and in production. GMP Labeling System products are designed in distinctive
shapes, sizes, colors and color-coded titles to prevent lost identities, mix-ups and errors.
Prompt, Courteous Service
Call or fax your order today and well ship today! Stock items shipped 2nd day guaranteed delivery in
the United States. Custom-designed labels can be printed and shipped within 48 hours.

Sincerely,

Jon Nickerson
Chief Executive Officer

STANDARD ROLL LABELS


Quality Control (Q series)
Status (S series)
Caution (C series)
Waste (W series)
Materials (M series)

COMPUTER-PRINT LABELS
Bill Sayre
President

Pin-feed labels (PF series and CP series)


Sheet-feed labels (LP series)

DESIGN-YOUR-OWN LABELS
How to design your own labels
Examples of customer-designed labels

To obtain free samples of any


of our standard labels just
call 800-637-4487

Visit our website


www.gmplabeling.com

Our labels comply with the


color coding system of the
Quality System Regulations:

Indicates Rejected, or
potential problem with
component or material

GMPrintsoftware to design and print labels

STANDARD and CUSTOM SIGNS


Standard signs
How to design your own signs

STANDARD OPERATING PROCEDURES


LABEL DISPENSERS
ORDERING INFORMATION

Indicates Hold or
Not Yet Accepted

Indicates Accepted
or Approved

Pages 8-9
8
9

Pages 10-13
10
12-13

Pages 14-15
14

Pages 16-17
16
17

Pages 18-19
Page 21
Pages 21-23

Design-your-own labels; standard and


custom signs; dispensers
SOPs
Roll labels
Pin-feed and sheet-feed labels

21
21
22-23
23

COMPLIANCE REFERENCE BOOKS

Back cover

References for FDA and ISO Compliance


GMP Labeling Inc. 2002

3
4-5
6
6
7

COLOR

NO.
ROLL

CAT.#

UNIT
PRICE

10% Disc.
2-5 Items

15% Disc.
6-11 Items

20% Disc.
12-24 Items

25% Disc.
25+ Items

1000
1000
1000
1000
1000
1000

C095
C098
C102
C114
C116

73.15
73.15
73.15
75.40
75.40
66.78

65.84
65.84
65.84
67.86
67.86
60.10

62.18
62.18
62.18
64.09
64.09
56.76

58.52
58.52
58.52
60.32
60.32
53.42

54.86
54.86
54.86
56.55
56.55
50.09

500
500
500

W932
W935
W936

81.78
81.78
81.78

73.60
73.60
73.60

69.51
69.51
69.51

65.42
65.42
65.42

61.34
61.34
61.34

CAUTION: C SERIES (SEE PAGE 6)


NOT FOR HUMAN USE*
FOR RESEARCH ONLY*
CAUTION: INVESTIGATIONAL DEVICE*
FOR EXPORT ONLY
FOR REFERENCE ONLY
* Available in smaller size

2" x 0.75"
2" x 0.75"
2" x 0.75"
2" x 1"
2" x 1"
1" x 0.5"

Blue/Yellow
Blue/Yellow
Black/White
White/Blue
Red/Yellow

4" X 2.5"
4" X 2.5"
4" X 2.5"

Black/Yellow
Black/Fluor Red
Black/Yellow

WASTE: W SERIES (SEE PAGE 6)


SCRAP
HAZARDOUS WASTE
WASTE FOR DISPOSAL

MATERIALS: M SERIES (SEE PAGE 7)


SAMPLE
SAMPLE
TEST SAMPLE
MATERIAL CONTROL
INVENTORY
SAMPLED
SAMPLED
QA RETAIN SAMPLE
RETURNED GOODS
UNIVERSAL-MATERIAL
UNIVERSAL-RESEARCH
UNIVERSAL C-SERIES
QC STABILITY
SOLUTION
BUFFER
REAGENT

1.5" x 1.5"
3.0" x 3.0"
2" x 1"
1.5" Circle
4" x 3.5"
2" Oval
3" x 2"
2.5" x 1.5"
2" x 3"
2" x 3"
1.5" x 2.5"
2" x 3"
2" x 2"
2" x 3"
2" x 3"
2" x 3"

Red/Yellow
Red/Yellow
Red/White
Red/Yellow
Red/Yellow
Red/Yellow
Red/Yellow
Red/Yellow
Red/Yellow
Red/White
Blue/White
Blue/White
Blue/White
Green/White
Blue/White
Gray/White

1000
500
1000
1000
500
1000
500
500
500
500
500
500
500
500
500
500

M023
M024
M025
M032
M035
M059
M069
M079
M193
M737
M792
M793
M795
M573R
M213R
M963R

75.40
83.49
75.40
75.40
84.67
83.04
72.90
65.70
72.90
72.90
65.70
72.90
71.80
72.90
72.90
72.90

67.86
75.14
67.86
67.86
76.20
74.74
65.61
59.13
65.61
65.61
59.13
65.61
64.62
65.61
65.61
65.61

64.09
70.97
64.09
64.09
71.97
70.58
61.97
55.85
61.97
61.97
55.85
61.97
61.03
61.97
61.97
61.97

60.32
66.79
60.32
60.32
67.74
66.43
58.32
52.56
58.32
58.32
52.56
58.32
57.44
58.32
58.32
58.32

56.55
62.62
56.55
56.55
63.50
62.28
54.68
49.28
54.68
54.68
49.28
54.68
53.85
54.68
54.68
54.68

Red/White
Red/White
Green/White
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Fluor Red

500
500
500
1000
500
500
500
500
500

S186PF
S188PF
S452PF
Q006PF
Q041PF
Q045PF
Q048PF
Q057PF
Q058PF

80.15
76.61
76.61
92.43
76.61
76.61
76.61
76.61
76.61

72.14
68.95
68.95
83.19
68.95
68.95
68.95
68.95
68.95

68.13
65.12
65.12
78.57
65.12
65.12
65.12
65.12
65.12

64.12
61.29
61.29
73.94
61.29
61.29
61.29
61.29
61.29

60.11
57.46
57.46
69.32
57.46
57.46
57.46
57.46
57.46

Red/White
Green/White
Black/Fluor Green
Black/Fluor Red
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Fluor Red

500
500
1000
1000
1000
500
500
500
500

S188CP
S452CP
Q004CP
Q005CP
Q006CP
Q041CP
Q045CP
Q057CP
Q058CP

76.61
76.61
92.43
92.43
92.43
76.61
76.61
76.61
76.61

68.95
68.95
83.19
83.19
83.19
68.95
68.95
68.95
68.95

65.12
65.12
78.57
78.57
78.57
65.12
65.12
65.12
65.12

61.29
61.29
73.94
73.94
73.94
61.29
61.29
61.29
61.29

57.46
57.46
69.32
69.32
69.32
57.46
57.46
57.46
57.46

Red/White
Red/White
Black/Yellow
Black/Yellow
Green/White
Black/Fluor Green
Black/Fluor Red
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Fluor Red

500
1000
2000
1000
1000
2000
2000
2000
1000
1000
1000
1000

S186LP
S188LP
Q007LP
Q050LP
S452LP
Q004LP
Q005LP
Q006LP
Q041LP
Q045LP
Q057LP
Q058LP

125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65

113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09

106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80

100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52

94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24

PIN-FEED: PF SERIES (SEE PAGE 8)


QUARANTINE
QUARANTINE
IN PROCESS
RELEASED
RELEASED
APPROVED
ACCEPTED
REJECTED
QC HOLD

4" x 2"
2" x 2"
2" x 2"
2" x 1"
2" x 2"
2" x 2"
2" x 2"
2" x 2"
2" x 2"

PIN-FEED: CP SERIES (SEE PAGE 8)


QUARANTINE
IN PROCESS
APPROVED
REJECTED
RELEASED
RELEASED
APPROVED
REJECTED
QC HOLD

2" x 2"
2" x 2"
2" x 1"
2" x 1"
2" x 1"
2" x 2"
2" x 2"
2" x 2"
2" x 2"

800-637-4487

Request free samples and


order labels and other
products on-line.

CREATE-YOUR-OWN LABELS

Pages 3-7

SIZE

ORDERING INFORMATION

The GMP Guarantee


You can return anything, any time, right down to the last label on the roll. No discussions, no problems.
You must be completely happy!

LABELS

SHEET-FEED: LP SERIES (SEE PAGE 9)


QUARANTINE
QUARANTINE
QUARANTINE
QUARANTINE
IN PROCESS
APPROVED
REJECTED
RELEASED
RELEASED
APPROVED
REJECTED
QC HOLD

4" x 2"
2" x 2"
2" x 1"
2" x 2"
2" x 2"
2" x 1"
2" x 1"
2" x 1"
2" x 2"
2" x 2"
2" x 2"
2" x 2"

23

ROLL LABELS
LABELS

SIZE

Prices on page 22

15% Disc. 20% Disc.


6-11 Items 12-24 Items

NO.
ROLL

CAT.#

UNIT

10% Disc.
2-5 Items

Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Silver
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Yellow
Black/Fluor Red
Black/Fluor Red
Black/Fluor Red
Black/Fluor Red
Black/Yellow
Black/Fluor Green
Black/Yellow
Black/Yellow
Blue/White

1000
500
500
1000
1000
500
1000
500
1000
1000
500
500
1000
500
500
500
1000
500
500

Q004
Q045
Q046
Q016
Q006
Q041
Q008
Q048
Q005
Q009
Q056
Q057
Q007
Q058
Q060
Q065
Q012
Q062
Q064

75.40
72.90
81.78
66.78
75.40
72.90
75.40
72.90
75.40
75.40
81.78
72.90
75.40
72.90
72.90
75.40
75.40
72.90
72.90

67.86
65.61
73.60
60.10
67.86
65.61
67.86
65.61
67.86
67.86
73.60
65.61
67.86
65.61
65.61
67.86
67.86
65.61
65.61

64.09
61.97
69.51
56.76
64.09
61.97
64.09
61.97
64.09
64.09
69.51
61.97
64.09
61.97
61.97
64.09
64.09
61.97
61.97

60.32
58.32
65.42
53.42
60.32
58.32
60.32
58.32
60.32
60.32
65.42
58.32
60.32
58.32
58.32
60.32
60.32
58.32
58.32

56.55
54.68
61.34
50.09
56.55
54.68
56.55
54.68
56.55
56.55
61.34
54.68
56.55
54.68
54.68
56.55
56.55
54.68
54.68

Black/White
Black/White
Black/White
Red/Silver
Red/Silver
Red/Silver
Red/Yellow
Red/White
Black/Fluor Red
Red/White
Red/White
Red/White
Black+Yellow/White
Red/Yellow
Black/Fluor Red
Red/White
Red/White
Green/White
Green/White
Red/White
Green/White
Red/Yellow
Green/White
Green/White
Green/White
Green/White
Black/Yellow
Blue/White
Red/White
Black/White

1000
1000
1000
1000
1000
1000
1000
1000
1000
500
500
500
1000
1000
500
1000
1000
500
500
1000
1000
500
500
500
500
500
500
500
500
500

S081
S089
S202
S103
S104
S105
S182
S183
S185
S186
S187
S188
S189
S190
S191
S195R
S197R
S200
S201
S314R
S315R
S316R
S318R
S319R
S451
S452
S511R
S846R
S179R
S685

66.78
75.40
75.40
62.18
66.78
62.18
75.40
75.40
75.40
81.78
72.90
65.70
75.40
75.40
72.90
75.40
75.40
72.90
72.90
75.40
75.40
65.70
72.90
65.70
72.90
65.70
65.70
65.70
65.70
72.90

60.10
67.86
67.86
55.96
60.10
55.96
67.86
67.86
67.86
73.60
65.61
59.13
67.86
67.86
65.61
67.86
67.86
65.61
65.61
67.86
67.86
59.13
65.61
59.13
65.61
59.13
59.13
59.13
59.13
65.61

56.76
64.09
64.09
52.85
56.76
52.85
64.09
64.09
64.09
69.51
61.97
55.85
64.09
64.09
61.97
64.09
64.09
61.97
61.97
64.09
64.09
55.85
61.97
55.85
61.97
55.85
55.85
55.85
55.85
61.97

53.42
60.32
60.32
49.74
53.42
49.74
60.32
60.32
60.32
65.42
58.32
52.56
60.32
60.32
58.32
60.32
60.32
58.32
58.32
60.32
60.32
52.56
58.32
52.56
58.32
52.56
52.56
52.56
52.56
58.32

50.09
56.55
56.55
46.64
50.09
46.64
56.55
56.55
56.55
61.34
54.68
49.28
56.55
56.55
54.68
56.55
56.55
54.68
54.68
56.55
56.55
49.28
54.68
49.28
54.68
49.28
49.28
49.28
49.28
54.68

Red/White
Green/Yellow
Green/Yellow
Black/Fluor Red
Black/Fluor Red
Green/Yellow
Black/Fluor Red
Green/Yellow
Blue/Yellow

500
1000
1000
1000
1000
1000
500
1000
1000

C077
C085
C087
C088
C118
C090
C091
C093
C094

71.80
82.04
82.04
73.15
71.80
75.40
65.70
73.15
73.15

64.62
73.84
73.84
65.84
64.62
67.86
59.13
65.84
65.84

61.03
69.73
69.73
62.18
61.03
64.09
55.85
62.18
62.18

57.44
65.63
65.63
58.52
57.44
60.32
52.56
58.52
58.52

53.85
61.53
61.53
54.86
53.85
56.55
49.28
54.86
54.86

COLOR

ROLL LABELS QUALITY CONTROL

(Q series)

800-637-4487

25% Disc.
25+ Items

ORDERING INFORMATION

800-637-4487

QUALITY CONTROL: Q
Q SERIES
SERIES (SEE
(SEEPAGE
PAGE3)3)
APPROVED
APPROVED
APPROVED
CE
RELEASED
RELEASED
ACCEPTED
ACCEPTED
REJECTED
REJECTED
REJECTED
REJECTED
QC HOLD
QC HOLD
QC HOLD
QC PASSED
HOLD
HOLD
QUALITY CONTROL

2" x 1"
2" x 3"
4" x 2.5"
1" x 0.5"
2" x 1"
2" x 3"
2" x 1"
2" x 3"
2" x 1"
2" x 1"
4" x 2.5"
2" x 3"
2" x 1"
2" x 3"
2" x 3"
1.5" Circle
2" x 1"
2" x 3"
2" x 3"

Q046

Q004

Q060

STATUS: S SERIES (SEE PAGES 4-5)


CALIBRATED
CALIBRATED
P.M.
CALIBRATION VOID IF SEAL IS BROKEN
CALIBRATION VOID IF SEAL IS BROKEN
VOID IF SEAL IS BROKEN
CALIBRATE BEFORE USE
CALIBRATION NOT REQUIRED
DO NOT USE: OUT OF CALIBRATION
QUARANTINE
QUARANTINE
QUARANTINE
QUARANTINE
QUARANTINE
MRB QUARANTINE
REWORK REQUIRED
RETURN TO VENDOR
PREVENTATIVE MAINTENANCE
CONDITIONAL RELEASE
DIRTY
CLEAN
TO BE CLEANED
CLEANED
CLEANED
IN PROCESS
IN PROCESS
ON TEST
STERILIZED
DEPYROGENATED
FILTER CHANGED

1" x 0.5"
2" x 1"
2" x 1"
0.5" circle
1" x 0.5"
0.5" circle
2" x 1"
2" x 1"
2" x 1"
4" x 2.5"
2" x 3"
2.5" x 1.5"
2" x 1"
2" x 1"
2" x 3"
2" x 1"
2" x 1"
2" x 3"
2" x 3"
1.5" circle
1.5" circle
2.5" x 1.5"
2" x 3"
2.5" x 1.5"
2" x 3"
2.5" x 1.5"
1.5" x 2.5"
2.5" x 1.5"
2.5" x 1.5"
2" x 3"

Q045

Q006
Q057

Q041

Q007
Q058
Q012
Q048

CAUTION: C SERIES (SEE PAGE 6)


NOT FOR CLINICAL USE
FREEZE UPON ARRIVAL
REFRIGERATE UPON ARRIVAL*
CAUTION: BIOHAZARD*
BIOHAZARD*
STERILE*
CAUTION: NON-STERILE*
REFRIGERATE: DO NOT FREEZE*
EXPIRATION DATE*

22

Q005

Q056

C SERIES continued on page 23

2" x 2"
3.5"x 1.25"
3.5" x 1.25"
2" x 0.75"
2" x 2"
2" x 1"
2.5" x 1.5"
2" x 0.75"
2" x 0.75"

Q062

NEW!
Q065

Q009
Q065
Q008

Q016

Q064

Labels shown actual size. Actual label colors may vary slightly. Red & green labels on this page are fluorescent.

ROLL LABELS STATUS

800-637-4487

(S series)

DESIGN-YOUR-OWN LABELS; SIGNS; SOFTWARE

Prices on page 22

DESIGN-YOUR-OWN SIGNS

DESIGN-YOUR-OWN LABELS PRICING

QUARANTINE
Mat:

A MULTI-USE LABEL!
Use labels Q004 through Q009 in this
space to indicate changing status such as
APPROVED or REJECTED

Lot #:

Sign size

Roll: per roll of 1000 labels. Pin-feed: per pack of 1000 labels.
Sheet-feed: per pack of 250 sheets. Labels per sheet: 10LP=40; 16LP=30; 17LP=18;
26LP=20; 20LP, 21LP=10; 53LP=6; 51LP, 50LP=4.
Options: Two ink colors, add 50%; blank labels, deduct 50%; sequential numbering,
add 50%; removable adhesive, add 10%. Fluorescent pin-feed stock, add 20%.
Clear label covers: to protect printing/writing on labels. Available on rolls to match all
label sizes. To order: specify size and use price of 50% of the corresponding custom
label price. For example:unit price for 2 x 1 label is $165.74; price for clear label is
$82.87. Standard volume discounts apply.

2 to 8 sq. in.
9 to 20 sq. in.
21 to 30 sq. in.
31 to 40 sq. in.
41 to 50 sq. in.

Price

Sign size

Price

19.26
23.36
30.55
36.72
42.88

51 to 60 sq. in.
61 to 70 sq. in.
71 to 80 sq. in.
81 to 90 sq. in.
91 to 100 sq. in.

49.04
55.20
61.36
67.53
74.71

Prices above are for signs up to 10 x 10.


For larger sizes call for a quotation.

P/N:

DESIGN-YOUR-OWN LABELS
Amt:

Size

Pending:

S187

By:

S188

1992 GMP Labeling

S187

S189

S186

QUARANTINE
Mat:

QUARANTINE
S190

1992 GMP Labeling

Amt:

Date:

By:

S190
S189

Lot #:

Amt:

By:

Date:

1995 GMP Labeling


1992 GMP Labeling

S188

ROLL LABELS

QUARANTINE
Lot #:

S191
S451

IN PROCESS

S511R

Mat:

CONDITIONAL
RELEASE

Lot #:

Mat:
P/N:
Lot #:

P/N:
Amt:

By:

Date:

S451

S201

S195R

1999 GMP Labeling, Inc.

S201

RETURN
TO VENDOR
S197R

1992 GMP Labeling

S452

IN PROCESS
Mat:

Lot #:

Amt:

By:

Date:

1995 GMP Labeling, Inc.

S197R
S452

Labels shown actual size. R signifies removable adhesive.

1992 GMP Labeling

SHEET-FEED LABELS

Notes:

PIN-FEED LABELS

By:
Date:

QUANTITY DISCOUNTS

STANDARD SIGNS

104.00
105.98
150.22
151.20
152.20
154.14
161.85
166.83
170.21
172.07
173.10
173.10
177.31
178.13
181.49
182.06
186.06
188.60
190.92
171.14
175.48
176.86
178.43
182.06
165.19
169.47
171.43
172.70
176.86
178.43
173.17
173.91
212.25
227.86
230.52
175.54
180.11
182.13
189.36
196.06
207.57
212.25
227.86
230.52
441.35
441.35
441.35
441.35
441.35
441.35
441.35
441.35
441.35

For Design-your-own labels, standard signs,


design-your-own signs and dispensers.
Qty. 2-5 = 10%; 6-11 = 15%; 12-24 = 20%; 25+ = 25%.

All signs 2 x 10; $20.25 each


Sign

STANDARD OPERATING PROCEDURES


GMProcedure

Cat. #

Price

DESIGN CONTROL
ENGINEERING CHANGE REQUEST
ENGINEERING CHANGE ORDER
DOCUMENTATION CHANGE CONTROL
MASTER & HISTORY RECORDS
FINISHED PRODUCT RELEASE
REGULATORY AGENCY INSPECTION
SELF-AUDIT
PERSONNEL TRAINING PROGRAM
MANAGEMENT RESPONSIBILITY
PURCHASING CONTROL
CALIBRATION CONTROL
LABELING CONTROL
PROCESS VALIDATION
NON-CONFORMING MATERIALS
MATERIAL REVIEW BOARD
PRODUCT DISTRIBUTION RECORDS
MEDICAL DEVICE REPORTING
SERVICING
CORRECTIVE AND PREVENTIVE ACTION
REPORTING OF FIELD CORRECTIONS AND REMOVALS

QS 1002
QS 1005
QS 1010
QS 1015
QS 1020
QS 1025
QS 1040
QS 1045
QS 1050
QS 1052
QS 1061
QS 1065
QS 1070
QS 1072
QS 1080
QS 1085
QS 1035
QS 1100
QS 1105
QS 1102
QS 1103

189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00

Group

ASOP
495.00

BSOP
345.00

CSOP
345.00

DSOP
295.00

ESOP
345.00

Quantity Discounts: Per GMProcedure: 2-5 items 10%; 6-11 items 15%; 12-20 items 20%.
Per Group: Any 2 groups 10%; any 3 groups 15%; any 4 groups 20%: all 5 groups 25%.

COMPUTER SOFTWARE
Cat. #

Price

P100W

98.00*

Item
GMPrint for Windows (XP, ME, 2000, 9x, 3x)
*GMPrint is supplied FREE with a $200 order for labels.

DISPENSERS
Label dispenser, metal
4
Label dispenser, metal
8
Label dispenser, metal
12
Label dispenser, Lucite blue/green 12
Label dispenser, Lucite red/rose
12

Holds 1 roll
Holds 2 to 3 rolls
Holds 3 to 5 rolls
Holds 3 to 5 rolls
Holds 3 to 5 rolls

D045
D085
D125
D200B
D200R

71.60
85.35
101.11
148.51
148.51

Terms: Net 30 days on approved credit.

The GMP Guarantee: You can return anything, any time.


No discussions, no problems. You must be happy.

ACCEPTED
APPROVED
CLEANED: _____________
FINISHED PRODUCT
FOR STERILIZATION
IN PROCESS
LOT# _________________
MATERIALS ON HOLD
MRB HOLD
NON-CONFORMING MATERIAL
NOT FOR PRODUCTION USE
ON TEST
QC HOLD
QUARANTINE
RAW MATERIALS
RELEASED
REJECTED
RETAINED SAMPLES
STERILIZED: ___________
CLEANROOM
GMP MANUFACTURING
MANUFACTURING
MICROBIOLOGY
PACKAGING
PACKAGING & LABELING
PRODUCTION
QUALITY ASSURANCE
QUALITY CONTROL
RECEIVING
RESEARCH & DEVELOPMENT
REWORK
SHIPPING
SHIPPING & RECEIVING
WAREHOUSE
AUTHORIZED PERSONNEL ONLY
CAUTION: NON STERILE
DO NOT ENTER
DO NOT OPEN
EYE PROTECTION REQUIRED
GLOVES REQUIRED
HAIR COVERING REQUIRED
KEEP DOOR CLOSED
LAB JACKETS REQUIRED
PROPER ATTIRE REQUIRED
GOWNING REQUIRED
Magnetic fasteners (2) $1.00
Sign holder, gold/silver $5.95

Cat. #
1048
1045
2318
3082
2092
2951
3080
1061
1060
1059
1062
2190
1058
2187
3081
1041
1057
3079
2845
5050
5008
5010
5065
5040
5042
5015
5020
5025
5038
5036
5018
5037
5039
5030
4940
2091
4086
4088
4092
4095
4093
4089
4096
4087
4094
6020
6050

800-637-4487

Amt:

1
2
3
4
5
6
8
9
10
11
13
16
17
18
19
20
21
22
23
29
27
26
25
24
65
35
34
33
32
30
36
37
53
51
50
10PF
16PF
17PF
26PF
20PF
21PF
53PF
51PF
60PF
10LP
16LP
17LP
26LP
20LP
21LP
53LP
51LP
50LP

Price

ORDERING INFORMATION

Date:

1 x 3/8
1 x 1/2
1-1/2 x 3/8
1-1/2 x 1/2
1-1/2 x 3/4
1-1/2 x 1
1-3/4 x 3/4
2 x 3/4
2x1
2 x 1-1/4
2-3/16 x 1
2-1/2 x 1
2-1/2 x1-1/2
3x1
3 x 1-1/2
3x2
4x2
4 x 2-1/2
3-7/8 x 3-3/8
1 Square
1-1/2 Square
2 Square
2-1/2 Square
3 Square
1/2 Circle
1 Circle
1-1/4 Circle
1-1/2 Circle
2 Circle
3 Circle
1-1/2 Oval
2 Oval
4x3
5x3
5x4
2x1
2-1/2 x 1
2-1/2 x 1-1/2
2x2
3x2
4x2
4x3
5x3
5x4
2x1
2-1/2 x 1
2-1/2 x 1-1/2
2x2
3x2
4x2
4x3
5x3
5x4

Cat. #

21

LABEL DISPENSERS

800-637-4487

Prices on page 21

ROLL LABELS STATUS

Prices on page 22

(S series)

800-637-4487

Versatile Lucite dispenser for roll labels


Easy accesslabels are separated
from the backing as you pull

By:

Date:

S315R

CLEAN

CLEANED

S319R

Date:

TO BE CLEANED

Date:

S315R

DIRTY

Prev. Run:

Item:

Lot #:

Ch. By:

Date:
By:

Table or wall mounting

S200

1993 GMP Labeling, Inc.

S318R

S318R

Sturdy metal dispensers

PREVENTATIVE MAINTENANCE
Equip:

S316R

FILTER CHANGED

S846R
1992 GMP Labeling

Type:
Item:
Equip:

By:

Date:

By:

Notes:

PM Date:
By:
Next Due:

PM Date:
By:
Next Due:

LI
CA

1992 GMP Labeling

S089

CALIBRATION
VOID
IF SEAL
IS BROKEN

Next Due:

NEW!

S846R

DEPYROGENATED

BRAT

S182

E
S183

BEFORE USING
S182

CALIBRATION
NOT REQUIRED

1995 GMP Labeling, Inc.

S103 & S104


Red ink on silver
Labels are tamper
evident

S183

Cal. Date:

S185

By:
Next Due:
ID#:

1992 GMP Labeling

CALIBRATION
VOID IF SEAL
IS BROKEN

S081

S104

S081
GMP

By:

S202

2001 GMP Labeling, Inc.

S202
P.M.:

Date:

GMP

ID#:

Next Due:

S103

By:

S089

ID#:

1999 GMP Labeling, Inc.

S685

CALIBRATION LABELS
Calibration Date:

S179R

1992 GMP Labeling

S105
tamper evident

20

VOID
IF SEAL
IS BROKEN

On the website you may also view (as well as


download and print) our Regulatory Compliance
Newsletters which provide articles on various
timely aspects of regulatory compliance, written by
authors with extensive experience in their fields.

PM Date:
By:
Next Due:

By:

The GMP Labeling website is a fast, easy way


to view and purchase our full line of GMP
compliance related products, encompassing labels,
signs, Standard Operating Procedures, and reference books for FDA compliance, ISO registration,
and use of the CE mark. As we add products during the year we post them to the website, so you
may learn about products not listed in this catalog.

PM Date:
By:
Next Due:

Next Due:

S685

Shop on-line for labels and other


GMP Labeling products.

PM Date:
By:
Next Due:

S200

WEBSITE: www.gmplabeling.com

PM Date:
By:
Next Due:

Item:

STERILIZED

Date:

Available in three sizes: 4 (1 roll) D045 ; 8 (2 to 3 rolls) D085; 12(3 to 5 rolls) D125

S314R

S314R

1992 GMP Labeling

Attractive, see-through
Lucite in two colors
blue/green (D200B) and
red/rose (D200R)

S179R

12-inch width dispenses 3 to


6 rolls, depending on
label size. Easily movable
label roll separators

1992 GMP Labeling

By:

S316R

Simple drop-in loading

Item:

Item:

Labels are fully enclosed,


keeping them safe, clean,
and ready-to-use

CLEANED

1992 GMP Labeling

S319R

S104
Labels shown actual size. * Also available in smaller size: 1x0.5. R signifies removable adhesive.

Prices on page 22, 23

1992 GMP Labeling C087

(C series)

REFRIGERATE

GMP

REFRIGERATE
DO NOT FREEZE

C093

ROLL LABELS CAUTION

800-637-4487

UPON ARRIVAL

C093*
C087*

UPON ARRIVAL

GMP

GMP

FREEZE

C088*

C085

NOT FOR
HUMAN USE

C095

C091*

C095*

800-637-4487

STANDARD OPERATING PROCEDURES

Compliance Group A: DOCUMENTATION Series

C085*

1992 GMP Labeling

FOR EXPORT
ONLY
1998 GMP Labeling

C114

C114

REGULATORY AGENCY INSPECTION: To describe the procedure for management of inspections by regulatory agencies
having legal authority over medical products manufactured or distributed. Cat. # QS1040.
SELF-AUDIT: To define a system for measuring conformance to applicable standards. Cat. # QS1045.
PERSONNEL TRAINING PROGRAM: To provide a system that assures that all employees are trained to properly perform their
assigned responsibilities. Cat. # QS1050.
MANAGEMENT RESPONSIBILITY: To describe the responsibility of executive management for establishing, implementing, and
maintaining quality policy and organization. Cat. # QS1052.

Compliance Group C: CONTROL Series

1998 GMP Labeling

NEW!

C102*

Catalog # CSOP

PURCHASING CONTROL: To assure that all items purchased for use in or with products comply with quality requirements.
Cat. # QS1061.
CALIBRATION CONTROL: To ensure that specified instruments and equipment maintain the accuracy and precision
required to produce safe and effective products. Cat. # QS1065.
LABELING CONTROL: To describe the procedure for control and accountability of product labeling. Cat. # QS1070.
PROCESS VALIDATION: To establish documented validation procedures for specified manufacturing processes and activities to
ensure that the output of those processes and activities consistently meets specified requirements. Cat. # QS1072.

C118

Compliance Group D: MATERIAL Series

BIOHAZARD

C118

Labels above shown actual size

ROLL LABELS WASTE


Waste Series labels
actual size: 2.5 x 4

* Also available in smaller size: 1x0.5.

(W series)

W935

W932

Catalog # DSOP

NON-CONFORMING MATERIALS: To describe a system for control and documentation of non-conforming or discrepant
materials. Cat. # QS1080.
MATERIAL REVIEW BOARD: To define the system for control, evaluation, disposition and documentation of non-conforming or discrepant materials. Cat. # QS1085.
PRODUCT DISTRIBUTION RECORDS: To assure that only those medical products approved for release are distributed, and
that traceability to the end user is maintained. Cat. # QS1035.

Compliance Group E: FIELD Series

W936

Catalog # BSOP

C077

FOR REFERENCE
USE ONLY
C116

C098

C094

C116

2001 GMP Labeling, Inc.

STERILE

C098*

FOR RESEARCH
USE ONLY

GMP

C090*

C090

C094*

GMP

EXPIRATION DATE

Catalog # ASOP

DESIGN CONTROL: To establish and maintain procedures to control the designs of medical devices to ensure that specified
design requirements are met. Cat. # QS1001.
ENGINEERING CHANGE REQUEST: To provide an Engineering Change Request (ECR) system to recommend the use of
changed materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1005.
ENGINEERING CHANGE ORDER: To provide an Engineering Change Order (ECO) system to initiate and authorize the use of
new or changed materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1010.
DOCUMENTATION CHANGE CONTROL: To provide a system to initiate, review, and authorize new or revised documentation.
Cat. # QS1015.
MASTER AND HISTORY RECORDS: To define the organization, content and use of the Master Records (MR) and History
Records (HR) employed in the production of all medical products. Cat. # QS1020.
FINISHED PRODUCT RELEASE: To define the system to assure that all finished products are released for commercial distribution only after conformance to all applicable manufacturing, quality, and regulatory requirements. Cat. # QS1025.

Compliance Group B: INSPECTION Series


Example of smaller size.

Prices on page 21

Catalog # ESOP

MEDICAL DEVICE REPORTING: To describe the procedure for mandatory reporting of adverse events and product problems to the Food and Drug Administration, using MedWatch, the FDA form 3500A. Cat. # QS1100.
SERVICING: To establish and maintain a system for servicing medical devices and verifying that the devices serviced meet
specified requirements. Cat. # QS1105.
CORRECTIVE AND PREVENTIVE ACTION: To describe a systematic approach to the analysis of product, process and
quality data to identify existing and potential causes of nonconforming product or other quality problems, and to describe the
implementation of corrective and preventive action. Cat. # QS1102.
REPORTING OF FIELD CORRECTIONS AND REMOVALS: To describe the requirements and process for reporting to the
FDA field corrections and removals (field remedial actions) that are initiated to reduce a risk to health. Cat. # QS1103.

19

STANDARD OPERATING PROCEDURES


Standard Operating Procedures

800-637-4487

ROLL LABELS MATERIALS

Prices on page 23

(M series)

800-637-4487

M069

Reporting Forms

GMP Labelings GMProcedures comprise a Quality System


combining Procedures (SOPs), reports for evidence of GMP
compliance, and log books to track compliance histories.

C
O
M
P
A
N
Y

FINISHED PRODUCT
RELEASE FORM

Form #:__________
Rev.:_____________

Quality Record No.: ______________________________

Date:____________

SOP#:_______________ Rev.:____________ Date:_______________


Item:

Sales Order #

P/N:

Ser./Lot #

Supplier:

Qty:

Date:

By:

Description:

Easily Customized to Your Needs


The SOPs reflect GMP and ISO 9000 requirements, and serve
as a prototype or template for you to customize to your
individual situation. The SOPs are furnished in computer
format for easy adaptation using a word processor. Its
simple, and youll probably save weeks of work on each SOP.

PART 1. MANUFACTURING RELEASE

C
O
M
P
A
N
Y

Mfg. Doc. (list):

SOPs (list):SURVEY REPORT


SUPPLIER

THIS ITEM MEETS ALL


Form #:__________
REQUIREMENTS &
DOCUMENTATION IS COMPLETE

Rev.:_____________
Released By:

Quality Record No.: ______________________________

Date:____________
Date:

SOP#:_______________ Rev.:____________ Date:_______________

Notes:
Item:

Order #

P/N:

Supplier I.D.#:

Ser./Lot #

Qty:

Other:

C
O
M
P
A
N
Y

Date:

PART 2. QUALITY CONTROL RELEASE


Test/Inspect. Proc. (list): PREVENTIVE MAINTENANCE/
SOPs (list):

PART 1.REPORT
SUPPLIER
CALIBRATION

Supplier:

Production Facility:

Address:

Address:

Rev.:_____________
Date:____________

Phone#:

Contact:
Calibration Date:

Model #

Inst. ID:

Manufact. ID#:

Survey Sent
By:
Date:

SOP#:_______________ Rev.:____________
Date:_______________
Phone #:

Contact:

THIS ITEM MEETS ALL


REQUIREMENTS &
DOCUMENTATION IS COMPLETE

Form #:__________

Quality Record No.: ______________________________

Phone#:

Item:

M059

Released By:
Date:
Notes:

Phone#:

Prev. Maint. Date:

Location:
Cal. Proc. #:

By:

Satisf:

Unsat:

PART 2. MATERIALS
Maint. Proc. #:

By:

Materials to be Purchased:

Date:

P/N / CATALOG #: Specifications, documentation:

PART 3. QUALITY ASSURANCE RELEASE


PART 1. PREVENTIVE MAINTENANCE OBSERVATIONS

dard
Stan

Observations/Notes:
Record significant data/measurements/observations:

es
edur
c
o
r
gP
ratin
e
p
O

THIS ITEM DOES NOT MEET ALL


APPLICABLE REQUIREMENTS
Rejected By:
Date:

Released By: ____________________________________


______________________
PART 3. SUPPLIER COMPLIANCEDate:
STATEMENT

Reason:

Print Name/Title: _______________________________________________________________


MRB Convened:
Applicable Regulations: (1) _________________________________________ (2) _________________________________________
Yes______ No______
Supplier's statement of compliance to reg. standards. Include all licenses & registration #s:
PRODUCT
CANNOT
Notice: Any unusual operation
or findings must
be noted.BE RELEASED WITHOUT THE PROPER

PARTDept.
2. CALIBRATION
NOTES
For Quality
: RELEASED PRODUCT
Date:

Record
significant
Released
fromdata/measurements/observations:
Quarantine
Released By:

Date:

AUTHORIZATION

#:

REJECTED BY:
Placed in Quarantine

Qty:

Date:

PART 4. MANUFACTURING/CONTROL STATEMENT

By:

Quantity:

Notes:

Supplier's statement verifying conformance to appropriate manufacturing and quality practices:


1994 GMP Labeling , Inc.

GMPForms

RF2525

M079

M035

Notice: Any unusual operation or findings must be noted.

M193

Please use for additional notes/comments.

STATEMENT OF COMPANY OFFICER


Certification: I hereby verify that the statements herein are complete and true.

M024

M023

X ____________________________________________________________________
Print Name:

Title:

Phone #:

GMPForms

Calibration Label; Completed & Affixed.:

By:

Reviewed & Approved By:

Date:

1994 GMP Labeling , Inc.

RF6060

M032

Out of Calibration Label; Completed & Affixed.:

Date:

By:

Date:

Notes/Comments:

Date:

GMPForms

1994 GMP Labeling , Inc.

M795

RF6565

SOPs are supplied in


comuter format for
easy adaptation
using a word
processor.

M213R
M963R

M573R
A MULTI-USE LABEL!
Modify this label for different
purposes. Most C-Series labels
will fit in this space.

Log Books

M793

18

M737
M792

M025
Labels shown actual size.
R signifies removable adhesive.

800-637-4487

COMPUTER-PRINT LABELS

(PF & CP series)

Prices on page 23

Prices on page 21

DESIGN-YOUR-OWN SIGNS

Our PF Series of Pin-feed labels

Our CP Series of Pin-feed labels

How to design your own sign

are supplied in fan-fold sheets for printing on your


dot-matrix printer. PF Series labels come with preprinted headers and field identifiers. With GMPrint
software (page 14) you choose the text, typeface
style and size to print data in the label fields.

are supplied in fan-fold sheets for printing on your dotmatrix printer. CP Series labels come with preprinted
headers but without field identifiers. Because field identifiers are not preprinted, you can design your own
labels using GMPrint software.

If we dont have a standard sign to fit your needs,


its easy to design your own. Use one of the
Design-Your-Own Label tear-out forms and fax
it to us. If there isnt enough space on the form to
write your sign, use an additional piece of paper.
Follow the steps below.

Label Header
Field
Identifiers

800-637-4487

Label Header

Q006PF
2 x 1 Label

STYLE

Decide if your sign is to be landscape (horizontal) or


portrait (vertical) style.

SIZE

Specify the width and height of the sign. The


maximum dimensions are 24 x 24.
Maximum letter size is 2 high.

Q041CP

Q041PF

Q057CP
Q045CP

Q045PF

S452CP

Q048PF
S452PF

Select the color of the letters and the background


color of the sign. Your choices in color combinations
are:

Black

S188PF

Red
Blue
Ivory
Brown
Yellow
Gray

Q058CP
S188CP
2 x 1 Labels
Q006CP

Sign
Black, Blue, Light Blue, Green, Red,
Orange, Gray, Brown, Walnut
White, Yellow, Orange, Almond,
Brushed Brass, Brushed Aluminum
White, Yellow
White, Yellow
Oak
Ivory
Red, Black
Black

If youd prefer some other color


combination, call us.

MOUNTING

Each sign is shipped with two adhesive mounting


pads. You may have mounting holes in the sign,
at no additional cost. Specify where the holes are
to be placed top or side and how many
holes you want. Other mounting options are
magnetic fasteners (two per sign) and a sign
holder (in gold or silver) which can be screwed or
nailed to a door or wall.

COLORS

Letters
White

Q058PF

S186PF
4 x 2 Label

MESSAGE

Decide what your sign should say, and print this


clearly on the form. We will set the letter size according
to the dimensions of your sign.

2 x 2 Labels
Q057PF

Use this photo of standard GMP signs to help you


choose colors.

QUANTITY

The last step is to tell us how many signs you


want!

SIGN
LES
EXAMP

If youd like help designing your sign


call us at 800-637-4487.
Q005CP
Q004CP

8
Labels shown actual size

17

STANDARD SIGNS

4940
2091

CLEANED:

MANUFACTURING

4088
4092

NON-CONFORMING
MATERIAL

4095

MRB HOLD

GLOVES
REQUIRED

4093

5020

QUALITY
ASSURANCE

EYE PROTECTION
REQUIRED

HAIR COVERING
REQUIRED

4089

MATERIALS ON HOLD

LOT #

DO NOT OPEN

KEEP DOOR CLOSED

QUALITY CONTROL

4096

5065
5040
5042
5015

PRODUCTION

3080

PACKAGING &
LABELING

5025

IN PROCESS

PACKAGING

1061

FOR
STERILIZATION

MICROBIOLOGY

1060

FINISHED PRODUCT

1059

3082

GMP MANUFACTURING

2092

APPROVED

2951

5050

DO NOT ENTER

CLEANROOM

5008

CAUTION:
NOT STERILE

ACCEPTED

5010

AUTHORIZED
PERSONNEL ONLY

1048

CAUTION SERIES

1045

DEPARTMENT SERIES

2318

STATUS SERIES

Prices on page 21

4086

800-637-4487

LAB JACKETS
REQUIRED

Prices on page 23

COMPUTER-PRINT LABELS

800-637-4487

(LP SERIES)

Sheet-feed labels, our LP Series


are supplied on flat 8 1/2 x 11 sheets for your
laser printer. These labels come with preprinted
headers, shown on this page. Using GMPrint
(page 14) you specify your format and field identifiers. You may also specify the type style and
size for field identifiers and data.
With the printing quality of a laser printer,
your labels look just like preprinted labels!
GMP also offers blank labels for laser printing
with nothing preprinted (no headers or field
identifiers), allowing you to design your own
labels for any application (page 10), or create
labels with GMPrint (page 14).
2 x 1 Labels
S007LP
Q006LP
S452LP

16

ON TEST

REWORK

4087
4094

5038
5036

RESEARCH &
DEVELOPMENT

5018

RECEIVING

NOT FOR
PRODUCTION USE

PROPER ATTIRE
REQUIRED

Q041LP
Q004LP

5037

SHIPPING

QUARANTINE

5039

SHIPPING &
RECEIVING

RAW MATERIALS

GOWNING REQUIRED

S050LP

5030

You may order signs


on-line at
www.gmplabeling.com

S057LP
S188LP

WAREHOUSE
2 x 4 Label
S186LP

RELEASED

3079

REJECTED
RETAINED SAMPLES:
STERILIZED:

2 x 2 Labels
Q045LP

Q058LP

QC HOLD

2845

1057

1041

3081

2187

1058

2190

1062

Q005LP

Enhance compliance in all areas of your company.


GMP signs are color-keyed to the GMP Labeling System.
Signs are engraved and laminated for durability. Actual size 2 x 10.
Signs are supplied with adhesive pads for mounting. You may order your
signs with mounting holes (specifying placement at the top or sides).
Magnetic fasteners and sign holders (in gold or silver) are also available.
To design your own signs see page 17.

Feed preprinted or blank labels into your laser printer


and imprint your headers, field identifiers and data.

DESIGN-YOUR-OWN LABELS

800-637-4487

You design the labelwe do the rest


Design your custom labels following the steps
described below. If you have just a general idea of what
you want, call us and well complete the design for you,
at no charge. Then we will take care of printing your
custom labels.
You can have your custom labels supplied on rolls or, if
you intend to imprint the labels on your computer
printer, you can have them supplied either in sheets for
a laser printer or an ink jet printer, or with pin-feed
holes for a dot matrix printer.
For examples of the hundreds of different labels
designed by our customers, see pages 12, 13.
Design your label on one of the tear-out order forms,

Prices on page 21

Your options include:


80 different label sizes and shapes
12 different stock materials for roll labels,
10 different stocks for computer-print labels
5 different ink colors
18 different typefaces, in any size
sequential numbering
permanent or removable adhesive

then fax the form to us and we will print your labels in


the quantity requested. This service is provided without
additional charges for art layout, printing set-up, plates, or
ink changes. Turn-around is typically two days.

Take these steps to design your label

STYLE

Roll labels are supplied on gloss or non-gloss stock.


Computer-print labels are supplied on non-gloss (litho)
paper so you can print on them from your computer, or
write on them by hand. Computer-print labels come in
two styles: sheet-feed and pin-feed.
Sheet-feed labels are supplied in 8 1/2 x 11 sheets for
printing on a laser printer or inkjet printer. Pin-feed
labels are supplied in fan-fold sheets with tractor holes
for printing on a dot matrix printer.

SIZE

Choose from the standard sizes shown below, or ask us


for a custom size.

Prices on page 21

CREATE-YOUR-OWN LABELS

Blank label stock


Sheet-feed

Pin-feed

White litho
Green fluorescent
Red fluorescent
Yellow fluorescent
Pink fluorescent
Blue pastel
Gray pastel
Pink pastel
Yellow pastel
Tan pastel
Green pastel

White litho
Green fluorescent
Red fluorescent
Pink fluorescent

Sheet-feed labels are available blank (shown) or


partially preprinted.

Blank label sizes


STOCK

Roll labels
White gloss
Yellowgloss
Green fluorescent
Red fluorescent
Pink fluorescent
Orange fluorescent
Yellow litho
Bright silver foil
Bright gold foil
Clear Mylar
White litho
Process blue litho

INK COLORS

Black Blue Red Green Brown


You may have up to five colors on a label.

Computer-print
labels, sheet-feed
White litho
Green fluorescent
Red fluorescent
Yellow fluorescent
Blue pastel
Gray pastel
Pink pastel
Yellow pastel
Tan pastel
Green pastel
Computer-print
labels, pin-feed
White litho
Green fluorescent
Red fluorescent

800-637-4487

Sheet-feed

Pin-feed

10LP
16LP
17LP
26LP
20LP
21LP
53LP
51LP
50LP

10PF
16PF
17PF
26 PF
20 PF
21PF
53PF
51PF
50PF

2x1 in.
21/2 x 1 in.
21/2 x 11/2 in.
2 x 2 in.
3 x 2 in.
4 x 2 in.
4 x 3 in.
5 x 3 in.
5 x 4 in.

2x1 in.
21/2 x 1 in.
21/2 x 11/2 in.
2 x 2 in.
3 x 2 in.
4 x 2 in.
4 x 3 in.
5 x 3 in.
5 x 4 in.

Preprinted labels
Sheet-feed: select from the LP Series labels
shown on page 9.

Pin-feed: select from the CP-Series and PF-Series


labels shown on page 8.

Pin-feed (fan-folded) labels are available blank


or partially preprinted (shown).

Standard label sizes; custom sizes on request


Roll Labels

10

No.

Size (in.)

No.

Size (in.)

1
2
3
4
5
6
8
9
10
11
13
16

1 x 3/8
1 x 1/2
1 1/2 x 3/8
1 1/2 x 1/2
1 1/2 x 3/4
1 1/2 x 1
13/4 x 3/4
2 x 3/4
2x1
2 x 1 1/4
23/16 x 1
21/2 x 1

17
18
19
20
21
22
23
29
27
26
25

21/2 x 11/2
3x1
3 x 11/2
3x2
4x2
4 x 21/2
3 7/8 x 3 3/8
1 square
1 1/2 square
2 square
2 1/2 square

Sheet-Feed

Pin-Feed

No.

Size (in.)

No.

Size (in.)

No.

Size (in.)

24
65
35
34
33
32
30
36
37
53
51
50

3 square
1/2 circle
1 circle
1 1/4 circle
1 1/2 circle
2 circle
3 circle
1 1/2 oval
2 oval
4x3
5x3
5x4

10LP
16LP
17LP
26LP
20LP
21LP
53LP
51LP
50LP

2x1
21/2 x 1
21/2 x 11/2
2x2
3x2
4x2
4x3
5x3
5x4

10PF
16PF
17PF
26PF
20PF
21PF
53PF
51PF
60PF

2x1
21/2 x 1
21/2 x 11/2
2x2
3x2
4x2
4x3
5x3
5x4

Clear cover labels to protect hand writing or imprinting are available in all sizes. Roll labels can be supplied in any square size up to
26 inches. Sheet-feed labels can be supplied in any rectangular size up to 8-1/2 by 11.

Examples of partially preprinted sheet-feed labels


imprinted using GMPrint.

15

800-637-4487

CREATE-YOUR-OWN LABELS

Prices on page 21

DESIGN-YOUR-OWN LABELS

Prices on page 21

800-637-4487

GMPrint the easy way to create and print labels


GMPrint is a program developed specifically for
users to design and print their own labels. We
supply you with partially preprinted labels or
blank labels, and you do the rest.

hase

Purc

487
37-4 00
6
0
80
-32
all: 408-522 isa
V
Or c

MeliP
G
ng
Lab

e
n Driv
ingto
t Rem A 94087
s
e
W
525 nyvale, C
Sun

Design made easy


GMPrint runs under Windows (XP, ME, 2000, 9x or
3x) on your PC. Its easy to use simply follow
the directions on the screen.

e: (

Phon

TO:
SHIP

Zip:

e:
Nam
:
pany
m
o
C
s:
s
re
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e:
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pany
Com
e:
m
a
ct N
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BILL

:
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(
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State
(
:
x
a
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)

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All u
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r & lo
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r cas
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xt,
box
of te
riate
ction
prop
ch se check ap
a
e
r
Fo
and
size,

Size

Blank labels are supplied in sheet-feed or pin-feed


(fan-fold) form. Specify the stock color, and choose
the label size from the table. You may also specify
permanent or removable adhesive.

ate:
tion D

Cred

e:
Nam
:
pany
Com
:
s
s
Addre
City:

If youd like help


in design, just call us
at 800-637-4487!

x
Ame

xpira

rd E
it Ca

Date

Choose your label stock

rd
erCa
Mast

r No.

Orde

)
)
NO. age 11
SIZEtable on p

(see
wn
rs)
 Bro
Y:
k colo
en
NTIT
ve in
A
fi
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to
Q
 Gre
eed
(up
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in
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d
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r-prin
COL
Blue
pute ho
INK

m
o
it
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nt
ck
hite L
esce
 Bla
 W en Fluor ent
e
c
r
K
s
C
G
luore Sheet-feed
STO
ls
ed F
labe
 R ter-print,
Roll ite Gloss
ompu
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ho
 W ow Gloss cent C White Lit orescent
ll
es
lu

 Ye en Fluor ent
en F escent
e
r
G
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R
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ra
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ll
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 Br ht Gold
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 Ye
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)
1
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ge
Script ld
o
s, pa
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 Pr
mple
T10 mericana B tra Bold
ee sa
(s
x
A
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T11 mericana E
EST a
old
12 A
TYP

elvetic
d T 3 Times B ld Style
lique
T1 H lvetica Ob Condense
T1
ry O
e
Centu
T2 H lvetica Bold
T14 vant Garde
e
ld
15 A stile Bold
T3 H lvetica Bo Oblique
T
e
.
Euro Book
T4 H lvetica Bold
Cond
T16
e
Futura othic Bold
T5 H latino Bold alic
T17
de G
It
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ra
P
ld
T
o
T6
oB
T18
alatin
T7 P s Book
ra
T8 E s Demi
ra
le
ble)
T9 E
E
S4
Possib
availa
rgest
to 72
E SIZ
TYP
5 La size from 6
S
E
D
C
AB
point
S1
(Any
CDE

DE

ABC

On-screen
instructions
guide you in
creating your
own labels.

eed
ou n
e. If y
al siz f paper.
tu
c
a
o
tline,
heet
el ou a blank s
h lab
e
Sketc pace us
s
more

S2
S3

AB

DE

ABC

Create your label


Depending on whether you picked blank or
partially preprinted labels, type your headers,
field identifiers and data into GMPrint. Choose
the placement on the label, type styles and sizes,
and youre done. Just tell GMPrint how may labels
to print.

T1

Load blank or preprinted label stock into your


printer and imprint with GMPrint.

T2
T3
T4
T5

Add more to your label


GMPrint will print each label with a sequential
number, batch data, and date stamp.
Windows is a registered trademark of Microsoft Corp.

T6

GMPrint is FREE with


a $200 order of labels

T7
T8
T9
T10

14

TYPE STYLE
Helvetica
Helvetica Oblique
Helvetica Bold Condensed
Helvetica Bold
Helvetica Bold Oblique
Palatino Bold
Palatino Bold Italic
Eras Book
Eras Demi
Brush Script

T11
T12
T13
T14
T15
T16
T17
T18

Americana Bold
Americana
Extra Bold
Times Bold
Century Old Style
Avant Garde
Eurostile Bold
Futura Book
Trade Gothic Bold
Condensed

TYPE SIZE

All samples above are shown


in size S3 (14 pt)
S1

Helvetica

(6 pt)

S2 Helvetica (10 pt)


S3

Helvetica

S4

Helvetica

(14 pt)
(20 pt)

S5 Largest possible
You may also specify any point size
from 6 to 72.

11

EXAMPLES OF CUSTOMER-DESIGNED LABELS

800-637-4487

800-637-4487

P/N
LOT #
QTY
DATE

RELEASED

FRAGILE
MATERIAL

Date
By

PREVENTIVE MAINTENANCE
By:

Date Performed:

Date Due:

APPROVED

New
Lot
Do Not Use
MV/0713

12

13

EXAMPLES OF CUSTOMER-DESIGNED LABELS

800-637-4487

800-637-4487

P/N
LOT #
QTY
DATE

RELEASED

FRAGILE
MATERIAL

Date
By

PREVENTIVE MAINTENANCE
By:

Date Performed:

Date Due:

APPROVED

New
Lot
Do Not Use
MV/0713

12

13

800-637-4487

CREATE-YOUR-OWN LABELS

Prices on page 21

DESIGN-YOUR-OWN LABELS

Prices on page 21

800-637-4487

GMPrint the easy way to create and print labels


GMPrint is a program developed specifically for
users to design and print their own labels. We
supply you with partially preprinted labels or
blank labels, and you do the rest.

hase

Purc

487
37-4 00
6
0
80
-32
all: 408-522 isa
V
Or c

MeliP
G
ng
Lab

e
n Driv
ingto
t Rem A 94087
s
e
W
525 nyvale, C
Sun

Design made easy


GMPrint runs under Windows (XP, ME, 2000, 9x or
3x) on your PC. Its easy to use simply follow
the directions on the screen.

e: (

Phon

TO:
SHIP

Zip:

e:
Nam
:
pany
m
o
C
s:
s
re
Add

e:
Nam
pany
Com
e:
m
a
ct N
Conta

TO:
BILL

:
State
(
Fax:

City:
:
State
(
:
x
a
F
)

e: (

case
pper
All u
wer
r & lo
Uppe
e
r cas
e
w
All lo

s
Type

tyle

Des

abel

rint l

r-p
pute

om

nd c

la
n rol
w
o
r
ou
ign y

e: (

Phon

Phon

Zip:

nd

bear
mle
Y
usty
COPindicate typNfoe r case.

xt,
box
of te
riate
ction
prop
ch se check ap
a
e
r
Fo
and
size,

Size

Blank labels are supplied in sheet-feed or pin-feed


(fan-fold) form. Specify the stock color, and choose
the label size from the table. You may also specify
permanent or removable adhesive.

ate:
tion D

Cred

e:
Nam
:
pany
Com
:
s
s
Addre
City:

If youd like help


in design, just call us
at 800-637-4487!

x
Ame

xpira

rd E
it Ca

Date

Choose your label stock

rd
erCa
Mast

r No.

Orde

)
)
NO. age 11
SIZEtable on p

(see
wn
rs)
 Bro
Y:
k colo
en
NTIT
ve in
A
fi
U
to
Q
 Gre
eed
(up
-f
)
in
S
d
t, P
OR(
 Re
r-prin
COL
Blue
pute ho
INK

m
o
it
C
nt
ck
hite L
esce
 Bla
 W en Fluor ent
e
c
r
K
s
C
G
luore Sheet-feed
STO
ls
ed F
labe
 R ter-print,
Roll ite Gloss
ompu
h
ho
 W ow Gloss cent C White Lit orescent
ll
es
lu

 Ye en Fluor ent
en F escent
e
r
G
re

nt
luor
resc
G
ed F luoresce
Fluo scent
R
d
e
F
t 
 R k Fluore
scen  Yellow stel
e
r
in
o
P
a

eP
e Flu
rang
 Blu y
 O ow Litho oil
ra
F
ll
G k
 Ye ht Silver il
l
ig
Fo
 Pin ow Paste
 Br ht Gold
ll
ig
 Ye
 Br ar Mylar
n
a
te
T
as l
le
 C ite Litho Litho  Green P
h
e

)
1
1
 W cess Blu
ge
Script ld
o
s, pa
o
Brush
 Pr
mple
T10 mericana B tra Bold
ee sa
(s
x
A
E
YL
T11 mericana E
EST a
old
12 A
TYP

elvetic
d T 3 Times B ld Style
lique
T1 H lvetica Ob Condense
T1
ry O
e
Centu
T2 H lvetica Bold
T14 vant Garde
e
ld
15 A stile Bold
T3 H lvetica Bo Oblique
T
e
.
Euro Book
T4 H lvetica Bold
Cond
T16
e
Futura othic Bold
T5 H latino Bold alic
T17
de G
It
a
ra
P
ld
T
o
T6
oB
T18
alatin
T7 P s Book
ra
T8 E s Demi
ra
le
ble)
T9 E
E
S4
Possib
availa
rgest
to 72
E SIZ
TYP
5 La size from 6
S
E
D
C
AB
point
S1
(Any
CDE

DE

ABC

On-screen
instructions
guide you in
creating your
own labels.

eed
ou n
e. If y
al siz f paper.
tu
c
a
o
tline,
heet
el ou a blank s
h lab
e
Sketc pace us
s
more

S2
S3

AB

DE

ABC

Create your label


Depending on whether you picked blank or
partially preprinted labels, type your headers,
field identifiers and data into GMPrint. Choose
the placement on the label, type styles and sizes,
and youre done. Just tell GMPrint how may labels
to print.

T1

Load blank or preprinted label stock into your


printer and imprint with GMPrint.

T2
T3
T4
T5

Add more to your label


GMPrint will print each label with a sequential
number, batch data, and date stamp.
Windows is a registered trademark of Microsoft Corp.

T6

GMPrint is FREE with


a $200 order of labels

T7
T8
T9
T10

14

TYPE STYLE
Helvetica
Helvetica Oblique
Helvetica Bold Condensed
Helvetica Bold
Helvetica Bold Oblique
Palatino Bold
Palatino Bold Italic
Eras Book
Eras Demi
Brush Script

T11
T12
T13
T14
T15
T16
T17
T18

Americana Bold
Americana
Extra Bold
Times Bold
Century Old Style
Avant Garde
Eurostile Bold
Futura Book
Trade Gothic Bold
Condensed

TYPE SIZE

All samples above are shown


in size S3 (14 pt)
S1

Helvetica

(6 pt)

S2 Helvetica (10 pt)


S3

Helvetica

S4

Helvetica

(14 pt)
(20 pt)

S5 Largest possible
You may also specify any point size
from 6 to 72.

11

DESIGN-YOUR-OWN LABELS

800-637-4487

You design the labelwe do the rest


Design your custom labels following the steps
described below. If you have just a general idea of what
you want, call us and well complete the design for you,
at no charge. Then we will take care of printing your
custom labels.
You can have your custom labels supplied on rolls or, if
you intend to imprint the labels on your computer
printer, you can have them supplied either in sheets for
a laser printer or an ink jet printer, or with pin-feed
holes for a dot matrix printer.
For examples of the hundreds of different labels
designed by our customers, see pages 12, 13.
Design your label on one of the tear-out order forms,

Prices on page 21

Your options include:


80 different label sizes and shapes
12 different stock materials for roll labels,
10 different stocks for computer-print labels
5 different ink colors
18 different typefaces, in any size
sequential numbering
permanent or removable adhesive

then fax the form to us and we will print your labels in


the quantity requested. This service is provided without
additional charges for art layout, printing set-up, plates, or
ink changes. Turn-around is typically two days.

Take these steps to design your label

STYLE

Roll labels are supplied on gloss or non-gloss stock.


Computer-print labels are supplied on non-gloss (litho)
paper so you can print on them from your computer, or
write on them by hand. Computer-print labels come in
two styles: sheet-feed and pin-feed.
Sheet-feed labels are supplied in 8 1/2 x 11 sheets for
printing on a laser printer or inkjet printer. Pin-feed
labels are supplied in fan-fold sheets with tractor holes
for printing on a dot matrix printer.

SIZE

Choose from the standard sizes shown below, or ask us


for a custom size.

Prices on page 21

CREATE-YOUR-OWN LABELS

Blank label stock


Sheet-feed

Pin-feed

White litho
Green fluorescent
Red fluorescent
Yellow fluorescent
Pink fluorescent
Blue pastel
Gray pastel
Pink pastel
Yellow pastel
Tan pastel
Green pastel

White litho
Green fluorescent
Red fluorescent
Pink fluorescent

Sheet-feed labels are available blank (shown) or


partially preprinted.

Blank label sizes


STOCK

Roll labels
White gloss
Yellowgloss
Green fluorescent
Red fluorescent
Pink fluorescent
Orange fluorescent
Yellow litho
Bright silver foil
Bright gold foil
Clear Mylar
White litho
Process blue litho

INK COLORS

Black Blue Red Green Brown


You may have up to five colors on a label.

Computer-print
labels, sheet-feed
White litho
Green fluorescent
Red fluorescent
Yellow fluorescent
Blue pastel
Gray pastel
Pink pastel
Yellow pastel
Tan pastel
Green pastel
Computer-print
labels, pin-feed
White litho
Green fluorescent
Red fluorescent

800-637-4487

Sheet-feed

Pin-feed

10LP
16LP
17LP
26LP
20LP
21LP
53LP
51LP
50LP

10PF
16PF
17PF
26 PF
20 PF
21PF
53PF
51PF
50PF

2x1 in.
21/2 x 1 in.
21/2 x 11/2 in.
2 x 2 in.
3 x 2 in.
4 x 2 in.
4 x 3 in.
5 x 3 in.
5 x 4 in.

2x1 in.
21/2 x 1 in.
21/2 x 11/2 in.
2 x 2 in.
3 x 2 in.
4 x 2 in.
4 x 3 in.
5 x 3 in.
5 x 4 in.

Preprinted labels
Sheet-feed: select from the LP Series labels
shown on page 9.

Pin-feed: select from the CP-Series and PF-Series


labels shown on page 8.

Pin-feed (fan-folded) labels are available blank


or partially preprinted (shown).

Standard label sizes; custom sizes on request


Roll Labels

10

No.

Size (in.)

No.

Size (in.)

1
2
3
4
5
6
8
9
10
11
13
16

1 x 3/8
1 x 1/2
1 1/2 x 3/8
1 1/2 x 1/2
1 1/2 x 3/4
1 1/2 x 1
13/4 x 3/4
2 x 3/4
2x1
2 x 1 1/4
23/16 x 1
21/2 x 1

17
18
19
20
21
22
23
29
27
26
25

21/2 x 11/2
3x1
3 x 11/2
3x2
4x2
4 x 21/2
3 7/8 x 3 3/8
1 square
1 1/2 square
2 square
2 1/2 square

Sheet-Feed

Pin-Feed

No.

Size (in.)

No.

Size (in.)

No.

Size (in.)

24
65
35
34
33
32
30
36
37
53
51
50

3 square
1/2 circle
1 circle
1 1/4 circle
1 1/2 circle
2 circle
2 circle
1 1/2 oval
2 oval
4x3
5x3
5x4

10LP
16LP
17LP
26LP
20LP
21LP
53LP
51LP
50LP

2x1
21/2 x 1
21/2 x 11/2
2x2
3x2
4x2
4x3
5x3
5x4

10PF
16PF
17PF
26PF
20PF
21PF
53PF
51PF
60PF

2x1
21/2 x 1
21/2 x 11/2
2x2
3x2
4x2
4x3
5x3
5x4

Clear cover labels to protect hand writing or imprinting are available in all sizes. Roll labels can be supplied in any square size up to
26 inches. Sheet-feed labels can be supplied in any rectangular size up to 8-1/2 by 11.

Examples of partially preprinted sheet-feed labels


imprinted using GMPrint.

15

STANDARD SIGNS

4940
2091

CLEANED:

MANUFACTURING

4088
4092

NON-CONFORMING
MATERIAL

4095

MRB HOLD

GLOVES
REQUIRED

4093

5020

QUALITY
ASSURANCE

EYE PROTECTION
REQUIRED

HAIR COVERING
REQUIRED

4089

MATERIALS ON HOLD

LOT #

DO NOT OPEN

KEEP DOOR CLOSED

QUALITY CONTROL

4096

5065
5040
5042
5015

PRODUCTION

3080

PACKAGING &
LABELING

5025

IN PROCESS

PACKAGING

1061

FOR
STERILIZATION

MICROBIOLOGY

1060

FINISHED PRODUCT

1059

3082

GMP MANUFACTURING

2092

APPROVED

2951

5050

DO NOT ENTER

CLEANROOM

5008

CAUTION:
NOT STERILE

ACCEPTED

5010

AUTHORIZED
PERSONNEL ONLY

1048

CAUTION SERIES

1045

DEPARTMENT SERIES

2318

STATUS SERIES

Prices on page 21

4086

800-637-4487

LAB JACKETS
REQUIRED

Prices on page 23

COMPUTER-PRINT LABELS

800-637-4487

(LP SERIES)

Sheet-feed labels, our LP Series


are supplied on flat 8 1/2 x 11 sheets for your
laser printer. These labels come with preprinted
headers, shown on this page. Using GMPrint
(page 14) you specify your format and field identifiers. You may also specify the type style and
size for field identifiers and data.
With the printing quality of a laser printer,
your labels look just like preprinted labels!
GMP also offers blank labels for laser printing
with nothing preprinted (no headers or field
identifiers), allowing you to design your own
labels for any application (page 10), or create
labels with GMPrint (page 14).
2 x 1 Labels
S007LP
Q006LP
S452LP

16

ON TEST

REWORK

4087
4094

5038
5036

RESEARCH &
DEVELOPMENT

5018

RECEIVING

NOT FOR
PRODUCTION USE

PROPER ATTIRE
REQUIRED

Q041LP
Q004LP

5037

SHIPPING

QUARANTINE

5039

SHIPPING &
RECEIVING

RAW MATERIALS

GOWNING REQUIRED

S050LP

5030

You may order signs


on-line at
www.gmplabeling.com

S057LP
S188LP

WAREHOUSE
2 x 4 Label
S186LP

RELEASED

3079

REJECTED
RETAINED SAMPLES:
STERILIZED:

2 x 2 Labels
Q045LP

Q058LP

QC HOLD

2845

1057

1041

3081

2187

1058

2190

1062

Q005LP

Enhance compliance in all areas of your company.


GMP signs are color-keyed to the GMP Labeling System.
Signs are engraved and laminated for durability. Actual size 2 x 10.
Signs are supplied with adhesive pads for mounting. You may order your
signs with mounting holes (specifying placement at the top or sides).
Magnetic fasteners and sign holders (in gold or silver) are also available.
To design your own signs see page 17.

Feed preprinted or blank labels into your laser printer


and imprint your headers, field identifiers and data.

800-637-4487

COMPUTER-PRINT LABELS

(PF & CP series)

Prices on page 23

Prices on page 21

DESIGN-YOUR-OWN SIGNS

Our PF Series of Pin-feed labels

Our CP Series of Pin-feed labels

How to design your own sign

are supplied in fan-fold sheets for printing on your


dot-matrix printer. PF Series labels come with preprinted headers and field identifiers. With GMPrint
software (page 11) you choose the text, typeface
style and size to print data in the label fields.

are supplied in fan-fold sheets for printing on your dotmatrix printer. CP Series labels come with preprinted
headers but without field identifiers. Because field identifiers are not preprinted, you can design your own
labels using GMPrint software.

If we dont have a standard sign to fit your needs,


its easy to design your own. Use one of the
Design-Your-Own Label tear-out forms and fax
it to us. If there isnt enough space on the form to
write your sign, use an additional piece of paper.
Follow the steps below.

Label Header
Field
Identifiers

800-637-4487

Label Header

Q006PF
2 x 1 Label

STYLE

Decide if your sign is to be landscape (horizontal) or


portrait (vertical) style.

SIZE

Specify the width and height of the sign. The


maximum dimensions are 24 x 24.
Maximum letter size is 2 high.

Q041CP

Q041PF

Q057CP
Q045CP

Q045PF

S452CP

Q048PF
S452PF

Select the color of the letters and the background


color of the sign. Your choices in color combinations
are:

Black

S188PF

Red
Blue
Ivory
Brown
Yellow
Gray

Q058CP
S188CP
2 x 1 Labels
Q006CP

Sign
Black, Blue, Light Blue, Green, Red,
Orange, Gray, Brown, Walnut
White, Yellow, Orange, Almond,
Brushed Brass, Brushed Aluminum
White, Yellow
White, Yellow
Oak
Ivory
Red, Black
Black

If youd prefer some other color


combination, call us.

MOUNTING

Each sign is shipped with two adhesive mounting


pads. You may have mounting holes in the sign,
at no additional cost. Specify where the holes are
to be placed top or side and how many
holes you want. Other mounting options are
magnetic fasteners (two per sign) and a sign
holder (in gold or silver) which can be screwed or
nailed to a door or wall.

COLORS

Letters
White

Q058PF

S186PF
4 x 2 Label

MESSAGE

Decide what your sign should say, and print this


clearly on the form. We will set the letter size according
to the dimensions of your sign.

2 x 2 Labels
Q057PF

Use this photo of standard GMP signs to help you


choose colors.

QUANTITY

The last step is to tell us how many signs you


want!

SIGN
LES
EXAMP

If youd like help designing your sign


call us at 800-637-4487.
Q005CP
Q004CP

8
Labels shown actual size

17

STANDARD OPERATING PROCEDURES


Standard Operating Procedures

800-637-4487

ROLL LABELS MATERIALS

Prices on page 23

(M series)

800-637-4487

M069

Reporting Forms

GMP Labelings GMProcedures comprise a Quality System


combining Procedures (SOPs), reports for evidence of GMP
compliance, and log books to track compliance histories.

C
O
M
P
A
N
Y

FINISHED PRODUCT
RELEASE FORM

Form #:__________
Rev.:_____________

Quality Record No.: ______________________________

Date:____________

SOP#:_______________ Rev.:____________ Date:_______________


Item:

Sales Order #

P/N:

Ser./Lot #

Supplier:

Qty:

Date:

By:

Description:

Easily Customized to Your Needs


The SOPs reflect GMP and ISO 9000 requirements, and serve
as a prototype or template for you to customize to your
individual situation. The SOPs are furnished in computer
format for easy adaptation using a word processor. Its
simple, and youll probably save weeks of work on each SOP.

PART 1. MANUFACTURING RELEASE

C
O
M
P
A
N
Y

Mfg. Doc. (list):

SOPs (list):SURVEY REPORT


SUPPLIER

THIS ITEM MEETS ALL


Form #:__________
REQUIREMENTS &
DOCUMENTATION IS COMPLETE

Rev.:_____________
Released By:

Quality Record No.: ______________________________

Date:____________
Date:

SOP#:_______________ Rev.:____________ Date:_______________

Notes:
Item:

Order #

P/N:

Supplier I.D.#:

Ser./Lot #

Qty:

Other:

C
O
M
P
A
N
Y

Date:

PART 2. QUALITY CONTROL RELEASE


Test/Inspect. Proc. (list): PREVENTIVE MAINTENANCE/
SOPs (list):

PART 1.REPORT
SUPPLIER
CALIBRATION

Supplier:

Production Facility:

Address:

Address:

Rev.:_____________
Date:____________

Phone#:

Contact:
Calibration Date:

Model #

Inst. ID:

Manufact. ID#:

Survey Sent
By:
Date:

SOP#:_______________ Rev.:____________
Date:_______________
Phone #:

Contact:

THIS ITEM MEETS ALL


REQUIREMENTS &
DOCUMENTATION IS COMPLETE

Form #:__________

Quality Record No.: ______________________________

Phone#:

Item:

M059

Released By:
Date:
Notes:

Phone#:

Prev. Maint. Date:

Location:
Cal. Proc. #:

By:

Satisf:

Unsat:

PART 2. MATERIALS
Maint. Proc. #:

By:

Materials to be Purchased:

Date:

P/N / CATALOG #: Specifications, documentation:

PART 3. QUALITY ASSURANCE RELEASE


PART 1. PREVENTIVE MAINTENANCE OBSERVATIONS

dard
Stan

Observations/Notes:
Record significant data/measurements/observations:

es
edur
c
o
r
gP
ratin
e
p
O

THIS ITEM DOES NOT MEET ALL


APPLICABLE REQUIREMENTS
Rejected By:
Date:

Released By: ____________________________________


______________________
PART 3. SUPPLIER COMPLIANCEDate:
STATEMENT

Reason:

Print Name/Title: _______________________________________________________________


MRB Convened:
Applicable Regulations: (1) _________________________________________ (2) _________________________________________
Yes______ No______
Supplier's statement of compliance to reg. standards. Include all licenses & registration #s:
PRODUCT
CANNOT
Notice: Any unusual operation
or findings must
be noted.BE RELEASED WITHOUT THE PROPER

PARTDept.
2. CALIBRATION
NOTES
For Quality
: RELEASED PRODUCT
Date:

Record
significant
Released
fromdata/measurements/observations:
Quarantine
Released By:

Date:

AUTHORIZATION

#:

REJECTED BY:
Placed in Quarantine

Qty:

Date:

PART 4. MANUFACTURING/CONTROL STATEMENT

By:

Quantity:

Notes:

Supplier's statement verifying conformance to appropriate manufacturing and quality practices:


1994 GMP Labeling , Inc.

GMPForms

RF2525

M079

M035

Notice: Any unusual operation or findings must be noted.

M193

Please use for additional notes/comments.

STATEMENT OF COMPANY OFFICER


Certification: I hereby verify that the statements herein are complete and true.

M024

M023

X ____________________________________________________________________
Print Name:

Title:

Phone #:

GMPForms

Calibration Label; Completed & Affixed.:

By:

Reviewed & Approved By:

Date:

1994 GMP Labeling , Inc.

RF6060

M032

Out of Calibration Label; Completed & Affixed.:

Date:

By:

Date:

Notes/Comments:

Date:

GMPForms

1994 GMP Labeling , Inc.

M795

RF6565

SOPs are supplied in


computer format for
easy adaptation
using a word
processor.

M213R
M963R

M573R
A MULTI-USE LABEL!
Modify this label for different
purposes. Most C-Series labels
will fit in this space.

Log Books

M793

18

M737
M792

M025
Labels shown actual size.
R signifies removable adhesive.

Prices on page 22, 23

1992 GMP Labeling C087

(C series)

REFRIGERATE

GMP

REFRIGERATE
DO NOT FREEZE

C093

ROLL LABELS CAUTION

800-637-4487

UPON ARRIVAL

C093*
C087*

UPON ARRIVAL

GMP

GMP

FREEZE

C088*

C085

NOT FOR
HUMAN USE

C095

C091*

C095*

800-637-4487

STANDARD OPERATING PROCEDURES

Compliance Group A: DOCUMENTATION Series

C085*

1992 GMP Labeling

FOR EXPORT
ONLY
1998 GMP Labeling

C114

C114

REGULATORY AGENCY INSPECTION: To describe the procedure for management of inspections by regulatory agencies
having legal authority over medical products manufactured or distributed. Cat. # QS1040.
SELF-AUDIT: To define a system for measuring conformance to applicable standards. Cat. # QS1045.
PERSONNEL TRAINING PROGRAM: To provide a system that assures that all employees are trained to properly perform their
assigned responsibilities. Cat. # QS1050.
MANAGEMENT RESPONSIBILITY: To describe the responsibility of executive management for establishing, implementing, and
maintaining quality policy and organization. Cat. # QS1052.

Compliance Group C: CONTROL Series

1998 GMP Labeling

NEW!

C102*

Catalog # CSOP

PURCHASING CONTROL: To assure that all items purchased for use in or with products comply with quality requirements.
Cat. # QS1061.
CALIBRATION CONTROL: To ensure that specified instruments and equipment maintain the accuracy and precision
required to produce safe and effective products. Cat. # QS1065.
LABELING CONTROL: To describe the procedure for control and accountability of product labeling. Cat. # QS1070.
PROCESS VALIDATION: To establish documented validation procedures for specified manufacturing processes and activities to
ensure that the output of those processes and activities consistently meets specified requirements. Cat. # QS1072.

C118

Compliance Group D: MATERIAL Series

BIOHAZARD

C118

Labels above shown actual size

ROLL LABELS WASTE


Waste Series labels
actual size: 2.5 x 4

* Also available in smaller size: 1x0.5.

(W series)

W935

W932

Catalog # DSOP

NON-CONFORMING MATERIALS: To describe a system for control and documentation of non-conforming or discrepant
materials. Cat. # QS1080.
MATERIAL REVIEW BOARD: To define the system for control, evaluation, disposition and documentation of non-conforming or discrepant materials. Cat. # QS1085.
PRODUCT DISTRIBUTION RECORDS: To assure that only those medical products approved for release are distributed, and
that traceability to the end user is maintained. Cat. # QS1035.

Compliance Group E: FIELD Series

W936

Catalog # BSOP

C077

FOR REFERENCE
USE ONLY
C116

C098

C094

C116

2001 GMP Labeling, Inc.

STERILE

C098*

FOR RESEARCH
USE ONLY

GMP

C090*

C090

C094*

GMP

EXPIRATION DATE

Catalog # ASOP

DESIGN CONTROL: To establish and maintain procedures to control the designs of medical devices to ensure that specified
design requirements are met. Cat. # QS1001.
ENGINEERING CHANGE REQUEST: To provide an Engineering Change Request (ECR) system to recommend the use of
changed materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1005.
ENGINEERING CHANGE ORDER: To provide an Engineering Change Order (ECO) system to initiate and authorize the use of
new or changed materials, products, procedures, processes, methods, and the defining documentation. Cat. # QS1010.
DOCUMENTATION CHANGE CONTROL: To provide a system to initiate, review, and authorize new or revised documentation.
Cat. # QS1015.
MASTER AND HISTORY RECORDS: To define the organization, content and use of the Master Records (MR) and History
Records (HR) employed in the production of all medical products. Cat. # QS1020.
FINISHED PRODUCT RELEASE: To define the system to assure that all finished products are released for commercial distribution only after conformance to all applicable manufacturing, quality, and regulatory requirements. Cat. # QS1025.

Compliance Group B: INSPECTION Series


Example of smaller size.

Prices on page 21

Catalog # ESOP

MEDICAL DEVICE REPORTING: To describe the procedure for mandatory reporting of adverse events and product problems to the Food and Drug Administration, using MedWatch, the FDA form 3500A. Cat. # QS1100.
SERVICING: To establish and maintain a system for servicing medical devices and verifying that the devices serviced meet
specified requirements. Cat. # QS1105.
CORRECTIVE AND PREVENTIVE ACTION: To describe a systematic approach to the analysis of product, process and
quality data to identify existing and potential causes of nonconforming product or other quality problems, and to describe the
implementation of corrective and preventive action. Cat. # QS1102.
REPORTING OF FIELD CORRECTIONS AND REMOVALS: To describe the requirements and process for reporting to the
FDA field corrections and removals (field remedial actions) that are initiated to reduce a risk to health. Cat. # QS1103.

19

LABEL DISPENSERS

800-637-4487

Prices on page 21

ROLL LABELS STATUS

Prices on page 22

(S series)

800-637-4487

Versatile Lucite dispenser for roll labels


Easy accesslabels are separated
from the backing as you pull

By:

Date:

S315R

CLEAN

CLEANED

S319R

Date:

TO BE CLEANED

Date:

S315R

DIRTY

Prev. Run:

Item:

Lot #:

Ch. By:

Date:
By:

Table or wall mounting

S200

1993 GMP Labeling, Inc.

S318R

S318R

Sturdy metal dispensers

PREVENTATIVE MAINTENANCE
Equip:

S316R

FILTER CHANGED

S846R
1992 GMP Labeling

Type:
Item:
Equip:

By:

Date:

By:

Notes:

PM Date:
By:
Next Due:

PM Date:
By:
Next Due:

LI
CA

1992 GMP Labeling

S089

CALIBRATION
VOID
IF SEAL
IS BROKEN

S846R

DEPYROGENATED

BRAT

S182

E
S183

BEFORE USING
S182

CALIBRATION
NOT REQUIRED

1995 GMP Labeling, Inc.

S103 & S104


Red ink on silver
Labels are tamper
evident

S183

Cal. Date:

S185

By:
Next Due:
ID#:

1992 GMP Labeling

CALIBRATION
VOID IF SEAL
IS BROKEN

S081

S104

S081

2001 GMP Labeling, Inc.

ID#:

GMP

Next Due:

S202

S202

By:

Date:

GMP

ID#:

Next Due:

S103

By:

S089

P.M.:

1999 GMP Labeling, Inc.

S685

CALIBRATION LABELS
Calibration Date:

S179R

1992 GMP Labeling

S105
tamper evident

20

VOID
IF SEAL
IS BROKEN

On the website you may also view (as well as


download and print) our Regulatory Compliance
Newsletters which provide articles on various
timely aspects of regulatory compliance, written by
authors with extensive experience in their fields.

PM Date:
By:
Next Due:

By:

The GMP Labeling website is a fast, easy way


to view and purchase our full line of GMP
compliance related products, encompassing labels,
signs, Standard Operating Procedures, and reference books for FDA compliance, ISO registration,
and use of the CE mark. As we add products during the year we post them to the website, so you
may learn about products not listed in this catalog.

PM Date:
By:
Next Due:

Next Due:

S685

Shop on-line for labels and other


GMP Labeling products.

PM Date:
By:
Next Due:

S200

WEBSITE: www.gmplabeling.com

PM Date:
By:
Next Due:

Item:

STERILIZED

Date:

Available in three sizes: 4 (1 roll) D045 ; 8 (2 to 3 rolls) D085; 12(3 to 5 rolls) D125

S314R

S314R

1992 GMP Labeling

Attractive, see-through
Lucite in two colors
blue/green (D200B) and
red/rose (D200R)

S179R

12-inch width dispenses 3 to


6 rolls, depending on
label size. Easily movable
label roll separators

1992 GMP Labeling

By:

S316R

Simple drop-in loading

Item:

Item:

Labels are fully enclosed,


keeping them safe, clean,
and ready-to-use

CLEANED

1992 GMP Labeling

S319R

S104
Labels shown actual size. * Also available in smaller size: 1x0.5. R signifies removable adhesive.

ROLL LABELS STATUS

800-637-4487

(S series)

DESIGN-YOUR-OWN LABELS; SIGNS; SOFTWARE

Prices on page 22

DESIGN-YOUR-OWN SIGNS

DESIGN-YOUR-OWN LABELS PRICING

QUARANTINE
Mat:

A MULTI-USE LABEL!
Use labels Q004 through Q009 in this
space to indicate changing status such as
APPROVED or REJECTED

Lot #:

Sign size

Roll: per roll of 1000 labels. Pin-feed: per pack of 1000 labels.
Sheet-feed: per pack of 250 sheets. Labels per sheet: 10LP=40; 16LP=30; 17LP=18;
26LP=20; 20LP, 21LP=10; 53LP=6; 51LP, 50LP=4.
Options: Two ink colors, add 50%; blank labels, deduct 50%; sequential numbering,
add 50%; removable adhesive, add 10%. Fluorescent pin-feed stock, add 20%.
Clear label covers: to protect printing/writing on labels. Available on rolls to match all
label sizes. To order: specify size and use price of 50% of the corresponding custom
label price. For example:unit price for 2 x 1 label is $165.74; price for clear label is
$82.87. Standard volume discounts apply.

2 to 8 sq. in.
9 to 20 sq. in.
21 to 30 sq. in.
31 to 40 sq. in.
41 to 50 sq. in.

Price

Sign size

Price

19.26
23.36
30.55
36.72
42.88

51 to 60 sq. in.
61 to 70 sq. in.
71 to 80 sq. in.
81 to 90 sq. in.
91 to 100 sq. in.

49.04
55.20
61.36
67.53
74.71

Prices above are for signs up to 10 x 10.


For larger sizes call for a quotation.

P/N:

DESIGN-YOUR-OWN LABELS
Amt:

Size

Pending:

S187

By:

S188

1992 GMP Labeling

S187

S189

S186

QUARANTINE
Mat:

QUARANTINE
S190

1992 GMP Labeling

Amt:

Date:

By:

S190
S189

Lot #:

Amt:

By:

Date:

1995 GMP Labeling


1992 GMP Labeling

S188

ROLL LABELS

QUARANTINE
Lot #:

S191
S451

IN PROCESS

S511R

Mat:

CONDITIONAL
RELEASE

Lot #:

Mat:
P/N:
Lot #:

P/N:
Amt:

By:

Date:

S451

S201

S195R

1999 GMP Labeling, Inc.

S201

RETURN
TO VENDOR
S197R

1992 GMP Labeling

S452

IN PROCESS
Mat:

Lot #:

Amt:

By:

Date:

1995 GMP Labeling, Inc.

S197R
S452

Labels shown actual size. R signifies removable adhesive.

1992 GMP Labeling

SHEET-FEED LABELS

Notes:

PIN-FEED LABELS

By:
Date:

QUANTITY DISCOUNTS

STANDARD SIGNS

104.00
105.98
150.22
151.20
152.20
154.14
161.85
166.83
170.21
172.07
173.10
173.10
177.31
178.13
181.49
182.06
186.06
188.60
190.92
171.14
175.48
176.86
178.43
182.06
165.19
169.47
171.43
172.70
176.86
178.43
173.17
173.91
212.25
227.86
230.52
175.54
180.11
182.13
189.36
196.06
207.57
212.25
227.86
230.52
441.35
441.35
441.35
441.35
441.35
441.35
441.35
441.35
441.35

For Design-your-own labels, standard signs,


design-your-own signs and dispensers.
Qty. 2-5 = 10%; 6-11 = 15%; 12-24 = 20%; 25+ = 25%.

All signs 2 x 10; $20.25 each


Sign

STANDARD OPERATING PROCEDURES


GMProcedure

Cat. #

Price

DESIGN CONTROL
ENGINEERING CHANGE REQUEST
ENGINEERING CHANGE ORDER
DOCUMENTATION CHANGE CONTROL
MASTER & HISTORY RECORDS
FINISHED PRODUCT RELEASE
REGULATORY AGENCY INSPECTION
SELF-AUDIT
PERSONNEL TRAINING PROGRAM
MANAGEMENT RESPONSIBILITY
PURCHASING CONTROL
CALIBRATION CONTROL
LABELING CONTROL
PROCESS VALIDATION
NON-CONFORMING MATERIALS
MATERIAL REVIEW BOARD
PRODUCT DISTRIBUTION RECORDS
MEDICAL DEVICE REPORTING
SERVICING
CORRECTIVE AND PREVENTIVE ACTION
REPORTING OF FIELD CORRECTIONS AND REMOVALS

QS 1001
QS 1005
QS 1010
QS 1015
QS 1020
QS 1025
QS 1040
QS 1045
QS 1050
QS 1052
QS 1061
QS 1065
QS 1070
QS 1072
QS 1080
QS 1085
QS 1035
QS 1100
QS 1105
QS 1102
QS 1103

189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00
189.00

Group

ASOP
395.00

BSOP
345.00

CSOP
345.00

DSOP
295.00

ESOP
345.00

Quantity Discounts: Per GMProcedure: 2-5 items 10%; 6-11 items 15%; 12-20 items 20%.
Per Group: Any 2 groups 10%; any 3 groups 15%; any 4 groups 20%: all 5 groups 25%.

COMPUTER SOFTWARE
Cat. #

Price

P100W

98.00*

Item
GMPrint for Windows (XP, ME, 2000, 9x, 3x)
*GMPrint is supplied FREE with a $200 order for labels.

DISPENSERS
Label dispenser, metal
4
Label dispenser, metal
8
Label dispenser, metal
12
Label dispenser, Lucite blue/green 12
Label dispenser, Lucite red/rose
12

Holds 1 roll
Holds 2 to 3 rolls
Holds 3 to 5 rolls
Holds 3 to 5 rolls
Holds 3 to 5 rolls

D045
D085
D125
D200B
D200R

71.60
85.35
101.11
148.51
148.51

Terms: Net 30 days on approved credit.

The GMP Guarantee: You can return anything, any time.


No discussions, no problems. You must be happy.

ACCEPTED
APPROVED
CLEANED: _____________
FINISHED PRODUCT
FOR STERILIZATION
IN PROCESS
LOT# _________________
MATERIALS ON HOLD
MRB HOLD
NON-CONFORMING MATERIAL
NOT FOR PRODUCTION USE
ON TEST
QC HOLD
QUARANTINE
RAW MATERIALS
RELEASED
REJECTED
RETAINED SAMPLES
STERILIZED: ___________
CLEANROOM
GMP MANUFACTURING
MANUFACTURING
MICROBIOLOGY
PACKAGING
PACKAGING & LABELING
PRODUCTION
QUALITY ASSURANCE
QUALITY CONTROL
RECEIVING
RESEARCH & DEVELOPMENT
REWORK
SHIPPING
SHIPPING & RECEIVING
WAREHOUSE
AUTHORIZED PERSONNEL ONLY
CAUTION: NON STERILE
DO NOT ENTER
DO NOT OPEN
EYE PROTECTION REQUIRED
GLOVES REQUIRED
HAIR COVERING REQUIRED
KEEP DOOR CLOSED
LAB JACKETS REQUIRED
PROPER ATTIRE REQUIRED
GOWNING REQUIRED
Magnetic fasteners (2) $1.00
Sign holder, gold/silver $5.95

Cat. #
1048
1045
2318
3082
2092
2951
3080
1061
1060
1059
1062
2190
1058
2187
3081
1041
1057
3079
2845
5050
5008
5010
5065
5040
5042
5015
5020
5025
5038
5036
5018
5037
5039
5030
4940
2091
4086
4088
4092
4095
4093
4089
4096
4087
4094
6020
6050

800-637-4487

Amt:

1
2
3
4
5
6
8
9
10
11
13
16
17
18
19
20
21
22
23
29
27
26
25
24
65
35
34
33
32
30
36
37
53
51
50
10PF
16PF
17PF
26PF
20PF
21PF
53PF
51PF
60PF
10LP
16LP
17LP
26LP
20LP
21LP
53LP
51LP
50LP

Price

ORDERING INFORMATION

Date:

1 x 3/8
1 x 1/2
1-1/2 x 3/8
1-1/2 x 1/2
1-1/2 x 3/4
1-1/2 x 1
1-3/4 x 3/4
2 x 3/4
2x1
2 x 1-1/4
2-3/16 x 1
2-1/2 x 1
2-1/2 x1-1/2
3x1
3 x 1-1/2
3x2
4x2
4 x 2-1/2
3-7/8 x 3-3/8
1 Square
1-1/2 Square
2 Square
2-1/2 Square
3 Square
1/2 Circle
1 Circle
1-1/4 Circle
1-1/2 Circle
2 Circle
3 Circle
1-1/2 Oval
2 Oval
4x3
5x3
5x4
2x1
2-1/2 x 1
2-1/2 x 1-1/2
2x2
3x2
4x2
4x3
5x3
5x4
2x1
2-1/2 x 1
2-1/2 x 1-1/2
2x2
3x2
4x2
4x3
5x3
5x4

Cat. #

21

ROLL LABELS
LABELS

SIZE

Prices on page 22

15% Disc. 20% Disc.


6-11 Items 12-24 Items

NO.
ROLL

CAT.#

UNIT

10% Disc.
2-5 Items

Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Silver
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Yellow
Black/Fluor Red
Black/Fluor Red
Black/Fluor Red
Black/Fluor Red
Black/Yellow
Black/Fluor Green
Black/Yellow
Black/Yellow
Blue/White

1000
500
500
1000
1000
500
1000
500
1000
1000
500
500
1000
500
500
500
1000
500
500

Q004
Q045
Q046
Q016
Q006
Q041
Q008
Q048
Q005
Q009
Q056
Q057
Q007
Q058
Q060
Q065
Q012
Q062
Q064

75.40
72.90
81.78
66.78
75.40
72.90
75.40
72.90
75.40
75.40
81.78
72.90
75.40
72.90
72.90
75.40
75.40
72.90
72.90

67.86
65.61
73.60
60.10
67.86
65.61
67.86
65.61
67.86
67.86
73.60
65.61
67.86
65.61
65.61
67.86
67.86
65.61
65.61

64.09
61.97
69.51
56.76
64.09
61.97
64.09
61.97
64.09
64.09
69.51
61.97
64.09
61.97
61.97
64.09
64.09
61.97
61.97

60.32
58.32
65.42
53.42
60.32
58.32
60.32
58.32
60.32
60.32
65.42
58.32
60.32
58.32
58.32
60.32
60.32
58.32
58.32

56.55
54.68
61.34
50.09
56.55
54.68
56.55
54.68
56.55
56.55
61.34
54.68
56.55
54.68
54.68
56.55
56.55
54.68
54.68

Black/White
Black/White
Black/White
Red/Silver
Red/Silver
Red/Silver
Red/Yellow
Red/White
Black/Fluor Red
Red/White
Red/White
Red/White
Black+Yellow/White
Red/Yellow
Black/Fluor Red
Red/White
Red/White
Green/White
Green/White
Red/White
Green/White
Red/Yellow
Green/White
Green/White
Green/White
Green/White
Black/Yellow
Blue/White
Red/White
Black/White

1000
1000
1000
1000
1000
1000
1000
1000
1000
500
500
500
1000
1000
500
1000
1000
500
500
1000
1000
500
500
500
500
500
500
500
500
500

S081
S089
S202
S103
S104
S105
S182
S183
S185
S186
S187
S188
S189
S190
S191
S195R
S197R
S200
S201
S314R
S315R
S316R
S318R
S319R
S451
S452
S511R
S846R
S179R
S685

66.78
75.40
75.40
62.18
66.78
62.18
75.40
75.40
75.40
81.78
72.90
65.70
75.40
75.40
72.90
75.40
75.40
72.90
72.90
75.40
75.40
65.70
72.90
65.70
72.90
65.70
65.70
65.70
65.70
72.90

60.10
67.86
67.86
55.96
60.10
55.96
67.86
67.86
67.86
73.60
65.61
59.13
67.86
67.86
65.61
67.86
67.86
65.61
65.61
67.86
67.86
59.13
65.61
59.13
65.61
59.13
59.13
59.13
59.13
65.61

56.76
64.09
64.09
52.85
56.76
52.85
64.09
64.09
64.09
69.51
61.97
55.85
64.09
64.09
61.97
64.09
64.09
61.97
61.97
64.09
64.09
55.85
61.97
55.85
61.97
55.85
55.85
55.85
55.85
61.97

53.42
60.32
60.32
49.74
53.42
49.74
60.32
60.32
60.32
65.42
58.32
52.56
60.32
60.32
58.32
60.32
60.32
58.32
58.32
60.32
60.32
52.56
58.32
52.56
58.32
52.56
52.56
52.56
52.56
58.32

50.09
56.55
56.55
46.64
50.09
46.64
56.55
56.55
56.55
61.34
54.68
49.28
56.55
56.55
54.68
56.55
56.55
54.68
54.68
56.55
56.55
49.28
54.68
49.28
54.68
49.28
49.28
49.28
49.28
54.68

Red/White
Green/Yellow
Green/Yellow
Black/Fluor Red
Black/Fluor Red
Green/Yellow
Black/Fluor Red
Green/Yellow
Blue/Yellow

500
1000
1000
1000
1000
1000
500
1000
1000

C077
C085
C087
C088
C118
C090
C091
C093
C094

71.80
82.04
82.04
73.15
71.80
75.40
65.70
73.15
73.15

64.62
73.84
73.84
65.84
64.62
67.86
59.13
65.84
65.84

61.03
69.73
69.73
62.18
61.03
64.09
55.85
62.18
62.18

57.44
65.63
65.63
58.52
57.44
60.32
52.56
58.52
58.52

53.85
61.53
61.53
54.86
53.85
56.55
49.28
54.86
54.86

COLOR

ROLL LABELS QUALITY CONTROL

(Q series)

800-637-4487

25% Disc.
25+ Items

ORDERING INFORMATION

800-637-4487

QUALITY CONTROL: Q
Q SERIES
SERIES (SEE
(SEEPAGE
PAGE3)3)
APPROVED
APPROVED
APPROVED
CE
RELEASED
RELEASED
ACCEPTED
ACCEPTED
REJECTED
REJECTED
REJECTED
REJECTED
QC HOLD
QC HOLD
QC HOLD
QC PASSED
HOLD
HOLD
QUALITY CONTROL

2" x 1"
2" x 3"
4" x 2.5"
1" x 0.5"
2" x 1"
2" x 3"
2" x 1"
2" x 3"
2" x 1"
2" x 1"
4" x 2.5"
2" x 3"
2" x 1"
2" x 3"
2" x 3"
1.5" Circle
2" x 1"
2" x 3"
2" x 3"

Q046

Q004

Q060

STATUS: S SERIES (SEE PAGES 4-5)


CALIBRATED
CALIBRATED
P.M.
CALIBRATION VOID IF SEAL IS BROKEN
CALIBRATION VOID IF SEAL IS BROKEN
VOID IF SEAL IS BROKEN
CALIBRATE BEFORE USE
CALIBRATION NOT REQUIRED
DO NOT USE: OUT OF CALIBRATION
QUARANTINE
QUARANTINE
QUARANTINE
QUARANTINE
QUARANTINE
MRB QUARANTINE
REWORK REQUIRED
RETURN TO VENDOR
PREVENTATIVE MAINTENANCE
CONDITIONAL RELEASE
DIRTY
CLEAN
TO BE CLEANED
CLEANED
CLEANED
IN PROCESS
IN PROCESS
ON TEST
STERILIZED
DEPYROGENATED
FILTER CHANGED

1" x 0.5"
2" x 1"
2" x 1"
0.5" circle
1" x 0.5"
0.5" circle
2" x 1"
2" x 1"
2" x 1"
4" x 2.5"
2" x 3"
2.5" x 1.5"
2" x 1"
2" x 1"
2" x 3"
2" x 1"
2" x 1"
2" x 3"
2" x 3"
1.5" circle
1.5" circle
2.5" x 1.5"
2" x 3"
2.5" x 1.5"
2" x 3"
2.5" x 1.5"
1.5" x 2.5"
2.5" x 1.5"
2.5" x 1.5"
2" x 3"

Q045

Q006
Q057

Q041

Q007
Q058
Q012
Q048

CAUTION: C SERIES (SEE PAGE 6)


NOT FOR CLINICAL USE
FREEZE UPON ARRIVAL
REFRIGERATE UPON ARRIVAL*
CAUTION: BIOHAZARD*
BIOHAZARD*
STERILE*
CAUTION: NON-STERILE*
REFRIGERATE: DO NOT FREEZE*
EXPIRATION DATE*

22

Q005

Q056

C SERIES continued on page 23

2" x 2"
3.5"x 1.25"
3.5" x 1.25"
2" x 0.75"
2" x 2"
2" x 1"
2.5" x 1.5"
2" x 0.75"
2" x 0.75"

Q062

NEW!
Q065

Q009
Q065
Q008

Q016

Q064

Labels shown actual size. Actual label colors may vary slightly. Red & green labels on this page are fluorescent.

ROLL, PIN-FEED, SHEET-FEED LABELS


The GMP Labeling System
Founded in 1987, GMP Labeling serves companies that are regulated by the FDA and/or are registered
for ISO 9000 standards. Today the GMP Labeling System is used daily in more than 5000 facilities in the
U.S., Canada and Europe.
The GMP Labeling System offers labels, signs and software that make it easier to comply with GMP
regulations and ISO 9000 requirements as well as demonstrating commitment to compliance. GMP
Labeling products help you identify components, pilot batches, raw materials, in-process materials, and
areas in your laboratory and in production. GMP Labeling System products are designed in distinctive
shapes, sizes, colors and color-coded titles to prevent lost identities, mix-ups and errors.
Prompt, Courteous Service
Call or fax your order today and well ship today! Stock items shipped 2nd day guaranteed delivery in
the United States. Custom-designed labels can be printed and shipped within 48 hours.

Sincerely,

Jon Nickerson
Chief Executive Officer

STANDARD ROLL LABELS


Quality Control (Q series)
Status (S series)
Caution (C series)
Waste (W series)
Materials (M series)

COMPUTER-PRINT LABELS
Bill Sayre
President

Pin-feed labels (PF series and CP series)


Sheet-feed labels (LP series)

DESIGN-YOUR-OWN LABELS
How to design your own labels
Examples of customer-designed labels

To obtain free samples of any


of our standard labels just
call 800-637-4487

Visit our website


www.gmplabeling.com

Our labels comply with the


color coding system of the
Quality System Regulations:

Indicates Rejected, or
potential problem with
component or material

GMPrintsoftware to design and print labels

STANDARD and CUSTOM SIGNS


Standard signs
How to design your own signs

STANDARD OPERATING PROCEDURES


LABEL DISPENSERS
ORDERING INFORMATION

Indicates Hold or
Not Yet Accepted

Indicates Accepted
or Approved

Pages 8-9
8
9

Pages 10-13
10
12-13

Pages 14-15
14

Pages 16-17
16
17

Pages 18-19
Page 21
Pages 21-23

Design-your-own labels; standard and


custom signs; dispensers
SOPs
Roll labels
Pin-feed and sheet-feed labels

21
21
22-23
23

COMPLIANCE REFERENCE BOOKS

Back cover

References for FDA and ISO Compliance


GMP Labeling Inc. 2002

3
4-5
6
6
7

COLOR

NO.
ROLL

CAT.#

UNIT
PRICE

10% Disc.
2-5 Items

15% Disc.
6-11 Items

20% Disc.
12-24 Items

25% Disc.
25+ Items

1000
1000
1000
1000
1000
1000

C095
C098
C102
C114
C116

73.15
73.15
73.15
75.40
75.40
66.78

65.84
65.84
65.84
67.86
67.86
60.10

62.18
62.18
62.18
64.09
64.09
56.76

58.52
58.52
58.52
60.32
60.32
53.42

54.86
54.86
54.86
56.55
56.55
50.09

500
500
500

W932
W935
W936

81.78
81.78
81.78

73.60
73.60
73.60

69.51
69.51
69.51

65.42
65.42
65.42

61.34
61.34
61.34

CAUTION: C SERIES (SEE PAGE 6)


NOT FOR HUMAN USE*
FOR RESEARCH ONLY*
CAUTION: INVESTIGATIONAL DEVICE*
FOR EXPORT ONLY
FOR REFERENCE ONLY
* Available in smaller size

2" x 0.75"
2" x 0.75"
2" x 0.75"
2" x 1"
2" x 1"
1" x 0.5"

Blue/Yellow
Blue/Yellow
Black/White
White/Blue
Red/Yellow

4" X 2.5"
4" X 2.5"
4" X 2.5"

Black/Yellow
Black/Fluor Red
Black/Yellow

WASTE: W SERIES (SEE PAGE 6)


SCRAP
HAZARDOUS WASTE
WASTE FOR DISPOSAL

MATERIALS: M SERIES (SEE PAGE 7)


SAMPLE
SAMPLE
TEST SAMPLE
MATERIAL CONTROL
INVENTORY
SAMPLED
SAMPLED
QA RETAIN SAMPLE
RETURNED GOODS
UNIVERSAL-MATERIAL
UNIVERSAL-RESEARCH
UNIVERSAL C-SERIES
QC STABILITY
SOLUTION
BUFFER
REAGENT

1.5" x 1.5"
3.0" x 3.0"
2" x 1"
1.5" Circle
4" x 3.5"
2" Oval
3" x 2"
2.5" x 1.5"
2" x 3"
2" x 3"
1.5" x 2.5"
2" x 3"
2" x 2"
2" x 3"
2" x 3"
2" x 3"

Red/Yellow
Red/Yellow
Red/White
Red/Yellow
Red/Yellow
Red/Yellow
Red/Yellow
Red/Yellow
Red/Yellow
Red/White
Blue/White
Blue/White
Blue/White
Green/White
Blue/White
Gray/White

1000
500
1000
1000
500
1000
500
500
500
500
500
500
500
500
500
500

M023
M024
M025
M032
M035
M059
M069
M079
M193
M737
M792
M793
M795
M573R
M213R
M963R

75.40
83.49
75.40
75.40
84.67
83.04
72.90
65.70
72.90
72.90
65.70
72.90
71.80
72.90
72.90
72.90

67.86
75.14
67.86
67.86
76.20
74.74
65.61
59.13
65.61
65.61
59.13
65.61
64.62
65.61
65.61
65.61

64.09
70.97
64.09
64.09
71.97
70.58
61.97
55.85
61.97
61.97
55.85
61.97
61.03
61.97
61.97
61.97

60.32
66.79
60.32
60.32
67.74
66.43
58.32
52.56
58.32
58.32
52.56
58.32
57.44
58.32
58.32
58.32

56.55
62.62
56.55
56.55
63.50
62.28
54.68
49.28
54.68
54.68
49.28
54.68
53.85
54.68
54.68
54.68

Red/White
Red/White
Green/White
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Fluor Red

500
500
500
1000
500
500
500
500
500

S186PF
S188PF
S452PF
Q006PF
Q041PF
Q045PF
Q048PF
Q057PF
Q058PF

80.15
76.61
76.61
92.43
76.61
76.61
76.61
76.61
76.61

72.14
68.95
68.95
83.19
68.95
68.95
68.95
68.95
68.95

68.13
65.12
65.12
78.57
65.12
65.12
65.12
65.12
65.12

64.12
61.29
61.29
73.94
61.29
61.29
61.29
61.29
61.29

60.11
57.46
57.46
69.32
57.46
57.46
57.46
57.46
57.46

Red/White
Green/White
Black/Fluor Green
Black/Fluor Red
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Fluor Red

500
500
1000
1000
1000
500
500
500
500

S188CP
S452CP
Q004CP
Q005CP
Q006CP
Q041CP
Q045CP
Q057CP
Q058CP

76.61
76.61
92.43
92.43
92.43
76.61
76.61
76.61
76.61

68.95
68.95
83.19
83.19
83.19
68.95
68.95
68.95
68.95

65.12
65.12
78.57
78.57
78.57
65.12
65.12
65.12
65.12

61.29
61.29
73.94
73.94
73.94
61.29
61.29
61.29
61.29

57.46
57.46
69.32
69.32
69.32
57.46
57.46
57.46
57.46

Red/White
Red/White
Black/Yellow
Black/Yellow
Green/White
Black/Fluor Green
Black/Fluor Red
Black/Fluor Green
Black/Fluor Green
Black/Fluor Green
Black/Fluor Red
Black/Fluor Red

500
1000
2000
1000
1000
2000
2000
2000
1000
1000
1000
1000

S186LP
S188LP
Q007LP
Q050LP
S452LP
Q004LP
Q005LP
Q006LP
Q041LP
Q045LP
Q057LP
Q058LP

125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65
125.65

113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09
113.09

106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80
106.80

100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52
100.52

94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24
94.24

PIN-FEED: PF SERIES (SEE PAGE 8)


QUARANTINE
QUARANTINE
IN PROCESS
RELEASED
RELEASED
APPROVED
ACCEPTED
REJECTED
QC HOLD

4" x 2"
2" x 2"
2" x 2"
2" x 1"
2" x 2"
2" x 2"
2" x 2"
2" x 2"
2" x 2"

PIN-FEED: CP SERIES (SEE PAGE 8)


QUARANTINE
IN PROCESS
APPROVED
REJECTED
RELEASED
RELEASED
APPROVED
REJECTED
QC HOLD

2" x 2"
2" x 2"
2" x 1"
2" x 1"
2" x 1"
2" x 2"
2" x 2"
2" x 2"
2" x 2"

800-637-4487

Request free samples and


order labels and other
products on-line.

CREATE-YOUR-OWN LABELS

Pages 3-7

SIZE

ORDERING INFORMATION

The GMP Guarantee


You can return anything, any time, right down to the last label on the roll. No discussions, no problems.
You must be completely happy!

LABELS

SHEET-FEED: LP SERIES (SEE PAGE 9)


QUARANTINE
QUARANTINE
QUARANTINE
QUARANTINE
IN PROCESS
APPROVED
REJECTED
RELEASED
RELEASED
APPROVED
REJECTED
QC HOLD

4" x 2"
2" x 2"
2" x 1"
2" x 2"
2" x 2"
2" x 1"
2" x 1"
2" x 1"
2" x 2"
2" x 2"
2" x 2"
2" x 2"

23

REFERENCE BOOKS

800-637-4487

ISO 9001:2000 for Small and Medium Sized Businesses


Herbert C. Monnich, Jr.
Herbert Monnich is an ASQ CQE, CRE,
and CQA who has been involved in the
development of the ISO 9000 system for
over ten years. He is a member of the U.S.
Task Group (TG 18) supporting the U.S.
TAG to ISO/TC 176/SC2/WG 18 the
committee that provided the input to the
ANSI/ISO/ASQ Q9000-2000 Series
Standard. Directed to those with little or no
ISO 9000 experience, this book explains
how the newly revised standards can effectively be implemented and maintained
without major expense or increase in staff. Techniques are provided
to simplify compliance for small and medium sized organizations.
154 pages, softcover. B952. $35.00

Quality Systems and GMP Regulations for Device


Manufacturers: A Practical Guide to U.S., European,
and ISO Requirements
Steven S. Kuwahara
Dr. Kuwahara is a biochemist and quality
control director, with expertise in quality
control/assurance and ISO 9000. This practical book will help the quality professional
establish a sound and documented quality
control system for device manufacturers that
will meet worldwide requirements. The
author explains step-by-step documentation
and implementation methods for every section of the U.S. Quality Systems Regulations
(21 CFR 820) and the Device Current Good
Manufacturing Practices (CGMP).
236 pages, hardcover. B951. $56.25

The Practical Guide to People-Friendly Documentation


Adrienne Escoe

Mastering and Managing the FDA Maze


Gordon Harnack
This book will help the reader understand
the basics of and gain insights into FDA
medical device compliance. The book
serves as a valuable reference for company
regulatory professionals, managers
responsible for FDA compliance, and FDA
neophytes requiring a broad resource.
According to the readers level of involvement with FDA compliance, the book clarifies those elements of the extensive FDA
regulations that the reader actually needs
to know. Mr. Harnack has over 25 years
experience in regulatory affairs, and is
currently President of the Oracle
Consulting Group, consultants to medical device manufacturers.
289 pages, softcover. B975. $49.00

ISO 9001:2000 Explained


Charles Cianfrani, Joseph Tsiakals, John West
ISO 9000:2000 represents the first major
revision to the quality standards since its
initial issue. In its second edition, this book is
the perfect companion to the new standard,
clarifying the changes in presentation, terminology, format, and requirements for quality
professionals. Mr. Cianfrani is the U.S. Expert
representative to ISO/TC 176/SC2/WG 18,
the Working Group that wrote 9001/4:2000.
Mr. Tsiakals is the medical device technical
expert on the ISO/TC 176 writing team for
ISO 9001:2000 and a founding member of the
ISO Medical Device Quality Committee. Mr.
West is chairman of the U.S. Technical
Advisory Group for ISO/TC 176 and Lead Delegate for the U.S. to
the ISO committee responsible for the ISO 9000 family of quality
management standards. 216 pages, hardcover. B965. $40.00

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GMP Labeling, Inc.


525 West Remington Drive
Sunnyvale, CA 94087

Customer Service
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Adrienne Escoe is president of


Escoe/Bliss Communication, where she is
a senior documentation and ISO 9000
compliance consultant. This book has
been thoroughly revised from its predecessor Nimble Documentation, to bring
together practical solutions to the documentation challenges faced by todays
organizations. From company policies
and desk instructions to Baldridge and
ISO 9000 requirements, it applies a
customer and quality-based systems
approach to streamlining and managing
your companys documentation system. The Guide is an organized
toolbox of methodologies that includes Internet, e-mail and webbased documentation management software.
228 pages, softcover. B942. $50.00

The FDA and Worldwide Quality


System Requirements Guidebook
for Medical Devices
Kimberly A. Trautman
Ms. Trautman is a GMP/Quality Systems
expert at the FDA Office of Compliance,
Center for Devices and Radiological
Health. Her book provides essential information regarding the new FDA regulation
for medical devices and international
quality system requirements (ISO 9001 and
ISO/DIS 13485). This guidebook helps manufacturers to establish a
single quality control system that satisfies world requirements.
210 pages, hardcover. B920. $45.00

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