Dirty: Your 2011 GMP and ISO 9000 Compliance Manual No. 21

2011
GMP Labeling
Your 2011 GMP and ISO 9000 Compliance Manual No. 21
Quality Control Labels
SOP Templates
Custom Labels
DIRTY
S314R
FRAGILE MATERIAL
APPROVED
PREVENTIVE MAINTENANCE
Date Performed:
By:
Q065
SCRAP
Date Due:
Over 200 Styles In Stock
Save Weeks of Work
Fast Turnaround
Serving Pharmaceutical and Medical Device Manufacturers Since 1987

22 New Labels Inside
ISO 9001 Certified
www.gmplabeling.com
800-637-4487
The GMP Labeling System
The GMP Labeling System

GMP Labeling has served companies regulated by the FDA or registered for ISO 9000 standards since 1987. We have 24 years of experience with GMP, ISO and QSR requirements. Today, the GMP Labeling System is used daily in more than 5,000 facilities in the U.S., Canada, Europe and throughout the world. The GMP Labeling System offers labels, signs and software for compliance with GMP regulations and ISO 9000 requirements. We save our customers time and can deliver the right products for your compliance identification needs. We ship Stock Labels in over 200 different styles with same day service. Custom order labels can be printed and shipped in as little as 48 hours. SOP forms are shipped with same day service. GMP Labeling pledges our commitment to the best, easiest and most courteous customer service to assist and process your order in four methods: Call (800) 637-4487. Customer service associates will answer your call within three rings. No frustrating automated telephone menu to navigate. Fax Your order specifications to (916) 771-4005. E-mail Your order specifications to sales@gmplabeling.com. Internet Send your order via our website at www.gmplabeling.com. Our purchasing process is quick, easy, and efficient. We will deliver the right products the first time. The GMP Labeling guarantee: You can return anything, anytime. No discussions, no problems. We thank you for your past business and pledge to maintain your confidence. Sincerely,
STANDARDROLLLABELS
Status (S series) Quality Control (Q series) Materials (M series) Waste (W series) Caution (C series)
Pages3-10
3-5 6-7 8-9 9 10
LABELDISPENSERS COMPUTER-PRINTLABELS
Sheet-feed labels (LP series)
Page11 Pages12-13
12 13
Pin-feed labels (PF series and CP series)
DESIGN-YOUR-OWNLABELS
Examples of customer-designed labels How to design your own labels
Pages15-17
15 16-17
CREATE-YOUR-OWNLABELS
Pages18-19
18 19
GMPrintsoftware to design and print labels Blank Labels
STANDARDandCUSTOMSIGNS
Standard signs
Pages20-21
20 21
How to design your own signs
STANDARDOPERATINGPROCEDURES Pages22-23 PRICINGINFORMATION

Pages24-27
Dispensers 11 Design-your-own labels; standard and custom signs 24 SOPs 24 Sheet-feed labels 25 Roll labels 25-27 Pin-feed labels 27
Our Labels are Color Coded
Our labels comply with the color coding system of the Quality System Regulations:
Indicates Rejected, or potential problem with component or material
Indicates Hold or Not Yet Accepted
Indicates Accepted or Approved
FREE Samples
800-637-4487
To obtain free samples of any of our stock labels call toll free:
Shop Online
Tom Markin President
Visit our website to order labels and other products on-line:
www.gmplabeling.com
Questions?
Send us an e-mail:
sales@gmplabeling.com
GMP Labeling Inc. 2011
A MULTI-USE LABEL Use labels Q004 through Q008 and Q012 in this space to indicate changing status such as APPROVED or REJECTED
ROLL LABELS STATUS
S511R S186
S190
(S series)
S189 S451
Mat:
S201
Prices on page 25 & 26
Lot #: By:
S188
Amt: Date:
1992 GMP Labeling
S188
3
S187 S452
Labels shown actual size. R signifies removable adhesive.
S191
To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com
Item:
CLEANED
By:
CLEAN
S315R
S315R
Date:
Prev. Run:
Lot #:
Ch. By:
Date:
S200 S318R
S846R S314R
DIRTY
S314R
S318R
1993 GMP Labeling, Inc.
VOID IF SEAL IS BROKEN
TAMPER EVIDENT
S105
(S series)
Item:
ROLL LABELS STATUS
By:
Date:
CLEANED
S685
S103 & S104 S103 Red Ink On Silver Tamper Evident Labels
S316R S182 S104
S319R
CALIBRATION VOID IF SEAL IS BROKEN
S183
1992 GMP Labeling
Calibration Date: By: Next Due: ID#:
1992 GMP Labeling
P Date: .M. By: Next Due: ID#:
S089
S185
Calibration Date:
1992 GMP Labeling
S088
P Date: .M. By: Next Due: ID#:
By:
S081 S080
Cal. Date: By: Next Due: ID#:
Cal. Date: By: Next Due: ID#:
Next Due: ID#:
S081
S080
S080, S088 and S203 are self-laminating to protect your entries.
S203 2001 GMP Labeling, Inc.
GMP
GMP
S088
S202 2001 GMP Labeling, Inc.
CALIBRATION NOT REQUIRED
S183
S089
S202
S203
S319R
1992 GMP Labeling
NEW
S173
DA
TE
INSTALL
ROLL LABELS STATUS
ED
S512
NEW
S512
NEW
S171
NEW
S199
(S series)
NEW NEW
S192
S195R
S193
NEW
S179
NEW
S170
S197R
5
NEW
S194
NEW
S175
NEW
S177
Q004
Prices on page 25
Q046
(Q series)
Q045
ROLL LABELS QUALITY CONTROL
Q008
Q006 Q007
Q048
Q041 Q058
Q005
6
Q057 Q056
Approved
Q067
QC
Q067
ROLL LABELS QUALITY CONTROL
NEW
NEW
Q063
Q065
Q065 Q013
NEW
Q044
Q012 Q062
NEW
(Q series)
Q068
Prices on page 25
NEW
Q069
7
Q060
NEW
Q014
Q064
Prices on page 27
M069
(M series)
M035 M024
M059
ROLL LABELS MATERIALS
M023 M213R M963R M792
M573R
A MULTI-USE LABEL Modify this label for different purposes. C-Series labels 2 x 1 and smaller labels will fit in this space.
8
M737 M793
M795
ROLL LABELS MATERIALS/WASTE
M025 M193 M111

#:
M032
M079
NEW
M115
ROLL LABELS WASTE
(W series)
W932, W935, W936 actual label size: 4 x 2.5
(M & W series)
W936
W932
Prices on page 27
9
W935
NEW
W930
C091*
C087*
Prices on page 26
Example of smaller size.
C091s
C-Series labels are shown actual size. Labels with an asterisk are available in a smaller size: 1 x 0.5. For example, C091s is the small version of label C091.
C085*
(C series)
C120*
C094* C093* C075
ROLL LABELS CAUTION
C088*
C116
C090*
C075
C118
NEW
C092
C114
2010 GMP Labeling C092
C098* C102
10
C095*
NEW
C104
NEW
C099
Versatile Lucite Dispenser for Roll Labels

Labels are fully enclosed, keeping them safe, clean, and ready-to-use. 12-inch width dispenses 3 to 6 rolls, depending on label size. Easily movable label roll separators. Attractive, see-through, blue/green Lucite (D200B). Table or wall mounting.
D200B
Easy accesslabels are separated from the backing as you pull
LABEL DISPENSERS
Sturdy Metal Dispensers

Three sizes to choose from (1, 3 or 5 roll capacity). Metal Construction makes these durable and easy to clean.
D045: 4 (1 roll)
D085: 8 (2 to 3 rolls)
D125: 12(3 to 5 rolls)
Prices on this page
DISPENSERS
Label dispenser, metal Label dispenser, metal Label dispenser, metal Label dispenser, Lucite blue/green 4 8 12 12 Holds 1 roll Holds 2 to 3 rolls Holds 3 to 5 rolls Holds 3 to 5 rolls D045 D085 D125 D200B 81.24 96.85 114.72 168.50
Label Dispensing Made Easy
11
Sheet-feed labels, our LP Series

are supplied on flat 8 x 11 sheets for your laser or inkjet printer. These labels come with preprinted headers, as shown on this page. Using GMPrint (page 18) you specify your format and field identifiers. You can also specify the type style and size for field identifiers and data.
Prices on page 25
With the printing quality of a laser or inkjet printer, your labels look just like preprinted labels! GMP Labeling also offers blank labels for printing (no headers or field identifiers), allowing you to design your own labels for any application (page 16), or to create labels with GMPrint software (page 18).
(LP SERIES)
S007LP Q006LP Q005LP
S452LP Q041LP Q045LP
COMPUTER-PRINT LABELS
Feed preprinted or blank labels into your printer and imprint your headers, field identifiers and data.
S050LP Q004LP Q008LP Q058LP Q057LP S188LP S451LP M573LPR

Q048LP
12
S186LP
Our PF Series of Pin-feed labels

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 18) you choose the text, typeface style and size to print data in the label fields.
Label Header Field Identifiers
Our CP Series of Pin-feed labels

are supplied in fan-fold sheets for printing on your dot-matrix 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.
COMPUTER-PRINT LABELS
Label Header
Q006PF
Q041PF Q057PF Q045PF Q048PF S452PF S188PF Q041CP Q057CP
(PF & CP series)

Prices on page 27
S186PF
Q006CP
Q005CP Q004CP
13
Labels shown actual size
Three Convenient Ways To Order: By Phone:

800-637-4487
We ship stock labels in over 200 different styles with same day service. Our labeling experts will save you time and help you choose the right product for your compliance identification needs.
DESIGN-YOUR-OWN LABELS
Prices on page 21
By Internet:
www.gmplabeling.com
The GMP Labeling website is a fast, easy way to view and purchase our full line of GMP compliance related products, including labels, facility signs and Standard Operating Procedures for FDA compliance and ISO registration. Browse through our products or download a catalog.
By Fax:
916-771-4005
Fax your Purchase Order directly to us. Our associates will call you back to confirm your order.
14
The GMP Labeling Guarantee Return Anything, Any Time, No Discussions, No Problems
CUSTOM LABELS
If you need a label that can withstand high temperatures, low temperatures, sterilization, or be clean room compatible, we can help you choose the right material and printing method to suit your needs. Custom labels can be designed and printed in as little as two days. Call us at 800-637-4487 and simply tell us what you need...we'll do the rest.
EXAMPLES OF CUSTOMER-DESIGNED LABELS
P/N LOT # QTY DATE

Date By
RELEASED
FRAGILE MATERIAL
APPROVED
PREVENTIVE MAINTENANCE
By: Date Due: Date Performed:
15
Custom labels to match your needs in a few easy steps

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. Thereisnochargefordesigncompletionandartlayout. Callusat800-637-4487orfaxusat916-771-4005.
Your options include: Almost any label size and shape 14 different stock materials for roll labels 12 different stocks for computer-print labels
Pricesonpage24

5 different ink colors A wide choice of type faces Sequential numbering Permanent or removable adhesive

STYLE
We offer a choice of three styles: roll, computer-print/sheet-feed and computer-print/pin-feed. Computer-print labels are supplied on non-gloss (matte) stock so you can print on them from your computer, or write on them by hand. Sheet-feed labels are supplied in 8-1/2 x 11 sheets for printing on a laser printer or inkjet printer. (250 sheets per pack.)
Roll labels are supplied on gloss or non-gloss stock. (1000 labels per roll.)
INK COLORS
Pin-feed Roll labels
Black Blue Red Green Brown You may have up to five colors on a label, choosing from the colors above or any PMS color you specify.
Pin-feed labels are supplied in fan-fold sheets with tractor holes for printing on a dot-matrix printer. (1000 labels per pack.)
SIZE
Your custom labels can be square, rectangular, circular or oval, in virtually any dimension. Roll labels can be as big as 26 square inches. Sheet-feed labels can be any rectangular size up to 8-1/2 by 11. Clear cover labels to protect hand writing or imprinting are available in all sizes.
STOCK
Roll labels White gloss Yellow gloss Green fluorescent Red fluorescent Pink fluorescent Orange fluorescent Blue fluorescent Purple fluorescent Yellow matte Bright silver foil Bright gold foil Clear Mylar White matte Process blue matte Computer-print sheet-feed labels White matte Green fluorescent Red fluorescent Yellow fluorescent Orange fluorescent Pink fluorescent Blue pastel Gray pastel Pink pastel Yellow pastel Tan pastel Green pastel Computer-print pin-feed labels White matte Green fluorescent Red fluorescent
16
Labels with permanent adhesive are supplied UNLESS removable adhesive is requested.
TYPE STYLE
(optional) Here are some examples of type styles. If you wish, choose one (or more) of these styles and indicate your choice on your label sketch. Or you can leave the choice of type style to us. If you have a particular type preference, tell us.
Helvetica Helvetica Oblique Helvetica Bold Condensed Helvetica Bold Helvetica Bold Oblique Palatino Bold Palatino Bold Italic TYPE SIZE (optional) Eras Book If you wish, indicate relative sizes for your label text (e.g. big, small, large as possible) on Eras Demi your sketch. Brush Script
Americana Bold Americana
Extra Bold Times Bold Century Old Style Avant Garde Eurostile Bold Futura Book Trade Gothic Bold Condensed
SKETCH YOUR LABEL DESIGN
(helpful, but also optional)
Pick the style of label you want Roll, Computer-print/sheet-feed or pin-feed. Following the example, sketch your label design on a sheet of paper or your letterhead and fax it to us at 916-771-4005. We will respond promptly with a quotation, and suggest options you may want to consider. Or, simply call us at 800-637-4487 and we will complete your design over the phone.
Prices on page 24
This is the finished label
17
You dont have to order large quantities. We handle orders as small as 1000 labels! To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com
GMPrint the easy way to create and print labels

GMPrint is a program we developed to make it easy for you to design and print your own labels. We can supply you with partially preprinted or blank labels, and you do the rest. GMPrint Version 6.2.3 works with networked printers, and is validatable at your facility. GMPrint runs under Windows* on your PC and operates with your existing hardware.
GMPrint includes two programs

The Designer program allows users to design and edit labels. The User program allows only entering data, which ensures label designs wont be altered without authorization.
Pricesonpage24
Validate GMPrint at your facility

Current GMP regulations require that, when computers are used as part of a quality system, the software must be validated for its intended use according to an established protocol. GMP Labeling has produced a set of protocols for testing GMPrint which we believe will satisfy regulatory requirements after you run tests and document the results at your facility. The validation protocols comprise a 33-page editable document.
CREATE-YOUR-OWN LABELS
Choose your label stock

Blank labels are supplied in sheet-feed or pin-feed form. Specify the stock color and label size, choosing from the options on page 15. You may also specify permanent or removable adhesive.
Create your label

Depending on whether you pick 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 many labels to print.
Add more to your label

GMPrint will print each label with a sequential number, batch data, and date stamp. Load blank or preprinted label stock into your printer and imprint with GMPrint.
* Windows Vista, XP, 2000, Me, 9x. Windows is a registered trademark of Microsoft Corp.
GMPrint is FREE
Simply download GMPrint from our website, www.gmplabeling.com. The download includes the Designer and User programs, images of all our standard computer-print labels, and the validation protocol document.
18
Sheet-feed blank labels

Stock Colors Sizes (inches) Labels/sheet White matte 10LP 2 x 1 40 Green fluorescent 16LP 21/2 x 1 30 Red fluorescent 17LP 21/2 x 11/2 21 Yellow fluorescent 26LP 2 x 2 20 Orange fluorescent 20LP 2 x 3 12* Pink fluorescent 21LP 4 x 2 10 Blue pastel 53LP 4 x 3 6 Gray pastel 51LP 5 x 3 4 Pink pastel 50LP 5 x 4 4 Yellow pastel * 10 labels / sheet if ordered in landscape layout. Tan pastel All labels sizes (10LP, 16LP, etc.) are Green pastel available in any of the colors listed.
CREATE-YOUR-OWN LABELS
Pin-feed blank labels

Stock Colors
White matte 10PF 2 x 1 Green fluorescent 16PF 21/2 x 1 Red fluorescent 17PF 21/2 x 11/2 26PF 2 x 2 20PF 3 x 2 21PF 4 x 2 53PF 4 x 3 51PF 5 x 3 50PF 5 x 4 All labels sizes (10PF, 16PF, etc.) are available in any of the colors listed.
Sheet-feed labels are available blank (shown) or partially preprinted.
Sizes (inches)
Preprinted labels
Sheet-feed: select from the LP Series labels
shown on page 3.
Pin-feed: select from the CP-Series and PF-Series

labels shown on page 9.
Pin-feed (fan-folded) labels are available blank or partially preprinted (shown).

Pricesonpage24
Examples of partially preprinted sheet-feed labels imprinted using GMPrint.
19
STATUS SERIES
1048
DEPARTMENT SERIES
CAUTION SERIES
AUTHORIZED PERSONNEL ONLY
CAUTION: NOT STERILE
4940 2091 4086 4088
ACCEPTED APPROVED
CLEANED:
CLEANROOM
GMP MANUFACTURING
MANUFACTURING
1045
2318
5010
5008
5050
DO NOT ENTER DO NOT OPEN

EYE PROTECTION REQUIRED GLOVES REQUIRED HAIR COVERING REQUIRED
3082
5065
FINISHED PRODUCT
FOR STERILIZATION
MICROBIOLOGY
2092
PACKAGING
PACKAGING & LABELING
Pricesonpage24
5042
3080
LOT #
PRODUCTION
QUALITY ASSURANCE
1061
5015
4093 4089
4095
IN PROCES S
2951
5040
4092
MATERIALS ON HOLD
1060
5025
STANDARD SIGNS
QUALITY CONTROL
NON-CONFORMING MATERIAL
RECEIVING
RESEARCH & DEVELOPMENT
1059
4096
MRB HOLD
5020
KEEP DOOR CLOSED

LAB JACKETS REQUIRED PROPER ATTIRE REQUIRED GOWNING REQUIRED
5038
NOT FOR PRODUCTION USE
1062
5036
ON TEST QC HOLD QUARANTINE

RAW MATERIALS
REWORK SHIPPING
SHIPPING & RECEIVING
2190
1058
5037
5018
2187
5039
WAREHOUSE
3081
RELEASED REJECTED
RETAINED SAMPLES:
STERILIZED:
1041
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 21.
2845
20
3079
1057
5030
www.gmplabeli ng.com
4094
4087
Order Signs On-line
How to Design Your Own Sign

If we dont have a standard sign to fit your needs, its easy to design your own. Follow the steps below:
Choose between either landscape (horizontal) or portrait (vertical) style.
STYLE
Specify the width and height of the sign. The maximum dimensions are 24 x 24. Maximum letter size is 2 high.
SIZE
DESIGN-YOUR-OWN SIGNS
Use this photo of standard GMP signs to help you choose colors.
Decide what your sign should say. We will set the letter size according to the dimensions of your sign.
MESSAGE
Select the color of the letters and the background color of the sign. Your choices in color combinations are:
COLORS
Letters
White Black Red Blue Ivory Brown Yellow Gray
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
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.
MOUNTING
The last step is to tell us how many signs you want!
QUANTITY
Prices on page 24
Additional color combinations are available!
ou Call Us If Y Help Would Like our Sign Designing Y
SIGN ES EXAMPL
87 800-637-44
21
Standard Operating Procedures

GMP Labeling's GMProcedures provide the framework for a Quality System by combining procedures (SOPs), reports for evidence of GMP compliance, and log books to track compliance histories.
DESIGNANDDOCUMENTCONTROLS
Medical Device Group Cat. #MD200 Pharmaceutical Group Cat. #PH200 DESIGN CONTROLS: To describe the requirements for the design control system which ensures that devices are designed to meet user needs, intended uses, and specified requirements. Cat. # MD20. DEVICE MASTER RECORD: To describe the organization, content, creation and use of the Device Master Record (DMR) employed in the production of all medical devices distributed by the manufacturer. Cat. # MD21. DOCUMENT AND CHANGE CONTROLS: To describe the process, procedures and requirements for controlling documents to assure that documents and changes are adequately evaluated, reviewed, and approved prior to implementation. Cat. # MD22; PH22. RISK MANAGEMENT: To describe the systematic management of the risks associated with the use of medical devices throughout the product life cycle from design to post-production. Risk management activities include analysis, evaluation, control, and post-production review. Risk management activities are also key elements of the Quality Management System. Cat. # MD23.
GMProcedures are addressed to medical device and pharmaceutical manufacturers

The SOPs provide a foundation for compliance with FDA pharmaceutical GMPs, FDA Quality System Regulations and the ISO 13485:2003 standard, and serve as a prototype or template for you to customize to your individual situation. Recognizing the differing needs, we offer separate SOPs for medical device manufacturers (MD series) and pharmaceutical manufacturers (PH series).
STANDARD OPERATING PROCEDURES
Easily customized to your needs

GMProcedures are supplied in computer format, on a CD. The SOPs, reports and log books are all furnished in Microsoft Word so you may easily adapt them to your specific requirements.
Time-saving templates
GMP Labeling has supplied SOP templates to the health care industry for 17 years, expanding their scope and adding procedures to reflect trends in compliance, such as risk management based on ISO 14971. Our SOPs include references and hyperlinks to important industry guidance documents.
CORRECTIVEANDPREVENTIVEACTION
Medical Device Group Cat. #MD300 Pharmaceutical Group Cat. #PH300 CORRECTIVE AND PREVENTIVE ACTION: To describe the systematic approach for establishing a corrective and preventive action (CAPA) system to capture non conformances, their related quality investigations and trends to prevent recurrence. This procedure discusses the communication and documentation activities associated with the CAPA system. Cat. # MD30; PH30. SERVICING: To describe instructions for performing servicing of finished, distributed medical devices and verifying that the serviced devices meet specified requirements. Cat. # MD31. PRODUCT RECALLS: To describe the requirements and process for determining whether a product recall, field correction, or removal is reportable to FDA and to define the reporting requirements for such actions. Cat. # MD32; PH32. MEDICAL DEVICE REPORTING: To describe the procedure for the mandatory reporting of adverse events and product problems to the FDA in accordance with the FDA's Medical Device Reporting Requirements. Cat. # MD33. COMPLAINT HANDLING: To describe the process for receiving, reviewing and evaluating complaints, and describe the responsibilities associated with the complaint handling process. This procedure also describes some elements of the customer communication and feedback process. Cat. # MD34; PH34. QUALITY INVESTIGATIONS: To describe the procedures for conducting and documenting investigations of non conformances which are a failure to meet predetermined material, product, process, facilities, equipment or system requirements or observations or trends that could potentially affect product quality. Cat. # MD35; PH35. ANNUAL PRODUCT REVIEWS: To describe the procedures for performing an annual product review (APR) of all product lots and related documentation. Cat. # PH36.
These SOPs are simple to use and they will save you weeks of work
For more information visit www.gmprocedures.com
MANAGEMENTCONTROLS
Medical Device Group Cat. #MD100 Pharmaceutical Group Cat. #PH100
22
QUALITY MANAGEMENT/UNIT RESPONSIBILITY: To describe the responsibilities for establishing, implementing and maintaining the Quality Management System to meet regulatory and customer requirements or to ensure established Quality Systems are in control of product quality following GMP. Cat. # MD10; PH10. INTERNAL QUALITY AUDITS: To describe the process and instructions for performing internal audits to assess the Quality Management System performance, assure it is in compliance with established requirements, and is operating effectively. Cat. # MD11; PH11. REGULATORY AGENCY INSPECTION: To describe the process for managing visits or inspections by regulatory agencies having legal authority over products manufactured or distributed by the Company. Cat. # MD12; PH12. PERSONNEL TRAINING PROGRAM: To describe a system that assures that all personnel are adequately trained to properly perform their assigned responsibilities. Cat. # MD13; PH13.
SOPs
LogBooks
STANDARD OPERATING PROCEDURES
PRODUCTIONANDPROCESSCONTROLS
Medical Device Group Cat. #MD400 Pharmaceutical Group Cat. #PH400 CALIBRATION AND PREVENTIVE MAINTENANCE: To describe the procedures for ensuring that inspection, measuring, test and process equipment are routinely calibrated, inspected, checked, and maintained to ensure fitness for use. Cat. # MD40; PH40. BUILDING/FACILITY SANITIZATION: To describe the general procedures for cleaning and sanitizing buildings and facilities used in the manufacture, processing, packaging or holding of the product in order to control and prevent product contamination. Cat. # MD41; PH41. PEST CONTROL PROGRAM: To describe the procedures for use of suitable rodenticides, insecticides, fungicides, or fumigating agents to prevent pest infestations of facilities used in the manufacture, processing, packaging and holding of the product. Cat. # MD42; PH42. EQUIPMENT CLEANING AND MAINTENANCE: To describe the general procedures for cleaning and maintenance of equipment used in the manufacture, processing, packaging and holding of the product. Cat. # PH43. CHARGE IN OF COMPONENTS: To describe procedures to establish production records with control on accurate addition and documentation of the labeled or established amount of controlled materials in a production batch of a drug product. Cat. # PH44. COMPONENT HANDLING AND SAMPLING: To describe procedures for receipt, inspection, segregation, sampling and disposition of controlled materials. Cat. # PH45. PROCESS VALIDATION/VALIDATION POLICY: To describe and document the policies and procedures for validation activities related to facilities, utilities, processes, test methods and equipment which directly or indirectly affect manufacture of the product. (This procedure does not cover GMP software validation.) Cat. # MD46; PH46. FINISHED PRODUCT RELEASE: To describe the procedures to assure that all finished products are tested and released for distribution only after verification of conformance to all applicable manufacturing, quality, and regulatory requirements. Cat. # MD47; PH47. SOFTWARE VALIDATION: To describe software validation activities to ensure that software complies with established software requirements and satisfies its intended use. Cat. # MD48; PH48.
ReportingForms
MATERIALCONTROLS
Medical Device Group Cat. #MD500 Pharmaceutical Group Cat. #PH500 PURCHASING CONTROLS / VENDOR QUALIFICATIONS: To describe the process for selection, approval, development and monitoring of suppliers providing components, materials and services used to support manufacture of the product. Cat. #MD50; PH50. NON CONFORMING MATERIALS & DEVIATIONS: To describe the process for the identification, documentation, evaluation, investigation, segregation and disposition of non conforming materials, and the handling of deviations from established procedures. Cat. #MD51; PH51. PRODUCT DISTRIBUTION AND WAREHOUSING: To describe the process to assure that only finished products approved for release are distributed and records are maintained for distribution activities, and to assure released products are stored under appropriate conditions to maintain their quality. This procedure also defines rotation of stock so that the oldest approved stock is distributed first, and traceability of product to readily determine each lot of product to facilitate its recall, if necessary. Cat. #MD52; PH52. RESERVE SAMPLES: To describe the procedures for the labeling, storage, inspection and maintenance of reserve samples representative of each lot of each active ingredient, excipient, or finished product. Cat. # PH 53. RETURNED GOODS: To describe procedures for receiving, identifying, documenting, dispositioning, and storing products returned after distribution to ensure the quality and safety of the product. Cat. # MD54; PH54. LABELING CONTROLS: To describe the procedure for the receipt, inspection, issuance, control of gang printing, accountability and use of labeling associated with medical device or pharmaceutical products. Cat. # MD55; PH55.
23
Prices on page 24
PRICING INFORMATION
DESIGN-YOUR-OWNLABELS
Size 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 2 x 1 2 x 1-1/4 2-3/16 x 1 2-1/2 x 1 2-1/2 x1-1/2 3 x 1 3 x 1-1/2 3 x 2 4 x 2 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 4 x 3 5 x 3 5 x 4 2 x 1 2-1/2 x 1 2-1/2 x 1-1/2 2 x 2 3 x 2 4 x 2 4 x 3 5 x 3 5 x 4 2 x 1 2-1/2 x 1 2-1/2 x 1-1/2 2 x 2 3 x 2 4 x 2 4 x 3 5 x 3 5 x 4 Cat. # 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 50PF 10LP 16LP 17LP 26LP 20LP 21LP 53LP 51LP 50LP Price 121.55 123.85 175.56 176.71 177.88 180.14 189.16 194.97 198.92 201.09 202.30 202.30 207.22 208.18 212.10 212.77 217.44 220.41 223.13 200.01 205.08 206.69 208.53 212.77 193.06 198.06 200.35 201.83 206.69 208.53 202.39 203.24 248.05 266.30 269.41 205.15 210.49 212.85 221.30 229.14 242.59 248.05 266.30 269.41 476.65 476.65 476.65 476.65 476.65 476.65 476.65 476.65 476.65
STANDARDOPERATINGPROCEDURES
Catalog # MD = Medical Device; PH = Pharmaceutical; NA = Not Applicable. 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%.
STANDARDSIGNS
All signs 2 x 10; $23.29. each Size ACCEPTED APPROVED AUTHORIZED PERSONNEL ONLY CAUTION: NOT STERILE CLEANED: _____________ CLEANROOM DO NOT ENTER DO NOT OPEN EYE PROTECTION REQUIRED FINISHED PRODUCT FOR STERILIZATION GLOVES REQUIRED GMP MANUFACTURING GOWNING REQUIRED HAIR COVERING REQUIRED IN PROCESS KEEP DOOR CLOSED LAB JACKETS REQUIRED LOT# _________________ MANUFACTURING MATERIALS ON HOLD MICROBIOLOGY MRB HOLD NON-CONFORMING MATERIAL NOT FOR PRODUCTION USE ON TEST PACKAGING PACKAGING & LABELING PRODUCTION PROPER ATTIRE REQUIRED QC HOLD QUALITY ASSURANCE QUALITY CONTROL QUARANTINE RAW MATERIALS RECEIVING REJECTED RELEASED RESEARCH & DEVELOPMENT RETAINED SAMPLES REWORK SHIPPING SHIPPING & RECEIVING STERILIZED: ___________ WAREHOUSE Magnetic fasteners (2) $1.00 Sign holder, gold/silver $10.75 Cat. # 1048 1045 4940 2091 2318 5050 4086 4088 4092 3082 2092 4095 5008 4094 4093 2951 4089 4096 3080 5010 1061 5065 1060 1059 1062 2190 5040 5042 5015 4087 1058 5020 5025 2187 3081 5038 1057 1041 5036 3079 5018 5037 5039 2845 5030 6020 6050
DESIGN-YOUR-OWN LABELS; SIGNS; SOFTWARE
MANAGEMENTCONTROLSGROUP(MD100&PH100) QUALITY MANAGEMENT/UNIT RESPONSIBILITY MD10 PH10 189.00 MD100 INTERNAL QUALITY AUDITS MD11 PH11 189.00 375.00 REGULATORY AGENCY INSPECTION MD12 PH12 189.00 PH100 PERSONNEL TRAINING PROGRAM MD13 PH13 189.00 375.00 DESIGN&DOCUMENTCONTROLSGROUP(MD200&PH200) DESIGN CONTROLS MD20 NA 189.00 MD200 DEVICE MASTER RECORD MD21 NA 189.00 375.00 DOCUMENT AND CHANGE CONTROLS MD22 PH22 189.00 PH200 RISK MANAGEMENT MD23 NA 189.00 189.00 CORRECTIVE&PREVENTIVEACTIONGROUP(MD300&PH300) CORRECTIVE AND PREVENTIVE ACTION MD30 PH30 189.00 SERVICING MD31 NA 189.00 MD300 PRODUCT RECALLS MD32 PH32 189.00 555.00 MEDICAL DEVICE REPORTING MD33 NA 189.00 COMPLAINT HANDLING MD34 PH34 189.00 PH300 QUALITY INVESTIGATIONS MD35 PH35 189.00 465.00 ANNUAL PRODUCT REVIEWS NA PH36 189.00 PRODUCTION&PROCESSCONTROLSGROUP(MD400&PH400) CALIBRATION AND PREVENTIVE MAINTENANCE MD40 PH40 189.00 BUILDING/FACILITY SANITIZATION MD41 PH41 189.00 MD400 PEST CONTROL PROGRAM MD42 PH42 189.00 555.00 EQUIPMENT CLEANING AND MAINTENANCE NA PH43 189.00 CHARGE IN OF COMPONENTS NA PH44 189.00 COMPONENT HANDLING AND SAMPLING NA PH45 189.00 PROCESS VALIDATION/VALIDATION POLICY MD46 PH46 189.00 PH400 FINISHED PRODUCT RELEASE MD47 PH47 189.00 825.00 SOFTWARE VALIDATION MD48 PH48 189.00 MATERIALSCONTROLSGROUP(MD500&PH500) PURCHASING CONTROLS/VENDOR QUAL. MD50 PH50 189.00 MD500 NON CONFORMING MATERIALS & DEVIATIONS MD51 PH51 189.00 465.00 PRODUCT DISTRIBUTION & WAREHOUSING MD52 PH52 189.00 RESERVE SAMPLES NA PH53 189.00 PH500 RETURNED GOODS MD54 PH54 189.00 555.00 LABELING CONTROLS MD55 PH55 189.00
GMProcedure
Cat. #
Price
Group
PIN-FEED LABELS
ROLL LABELS
DESIGN-YOUR-OWNSIGNS
Sign Size 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 26.47 32.13 42.00 50.49 58.96 Sign Size 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. Price 67.42 75.89 84.36 92.86 102.71
SHEET-FEED LABELS
Prices above are for signs up to 10 x 10. For larger sizes, call for a quotation.
DESIGN-YOUR-OWNLABELSPRICING
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=21; 26LP=20; 20LP=12; 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%. Clearlabelcovers: 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 $198.92; price for clear label is $99.46. Standard volume discounts apply.
24
hi Return anyt lems. ons, no prob No discussi
The GMP arantee Labeling Gu, any time. ng
LABELS
SOLUTION QUARANTINE QUARANTINE QUARANTINE QUARANTINE IN PROCESS IN PROCESS APPROVED REJECTED RELEASED ACCEPTED RELEASED APPROVED ACCEPTED REJECTED QC HOLD APPROVED REJECTED RELEASED QC HOLD ACCEPTED HOLD HOLD FOR INSPECTION AWAITING DISPOSITION RELEASED RECEIVED APPROVED APPROVED ACCEPTED REJECTED REJECTED QC HOLD QC HOLD HOLD HOLD QUALITY CONTROL QC PASSED QC APPROVED INSPECTED REINSPECT CALIBRATED (SELF-LAMINATING) CALIBRATED CALIBRATED (SELF-LAMINATING) CALIBRATED CALIBRATION VOID IF SEAL IS BROKEN CALIBRATION VOID IF SEAL IS BROKEN VOID IF SEAL IS BROKEN NON-CONFORMING CALIBRATION LOG CALIBRATION LOG
S SERIES continued on page 26
SIZE
2" x 3" 2" x 1" 2" x 2" 4" x 2" 2" x 2" 2" x 3" 2" x 2" 2" x 1" 2" x 1" 2" x 1" 2" x 1" 2" x 2" 2" x 2" 2" x 2" 2" x 2" 2" x 2" 2" x 1" 2" x 1" 2" x 1" 2" x 1" 2" x 1" 2" x 1" 2" x 1" 2" x 3" 2" x 1" 2" x 3" 4" x 2.5" 2" x 3" 4" x 2.5" 2" x 3" 2" x 3" 2" x 3" 2" x 3" 4" x 2.5" 2" x 3"
COLOR
Green/White Black/Yellow Black/Yellow Red/White Red/White Green/White Green/White Black/Fluor Green Black/Fluor Red Black/Fluor Green Black/Fluor Green Black/Fluor Green Black/Fluor Green Black/Fluor Green Black/Fluor Red Black/Fluor Red Black/Fluor Green Black/Fluor Red Black/Fluor Green Black/Fluor Red Black/Fluor Green Black/Yellow Black/Yellow Black/Fluor Green Black/White Black/Fluor Green Black/Fluor Green Black/Fluor Green Black/Fluor Red Black/Fluor Red Black/Fluor Red Black/Yellow Black/Yellow Black/Yellow Blue/White
NO. OF LABELS
600 2000 1000 500 1000 600 1000 2000 2000 2000 2000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 500 500 1000 500 500 500 500 500 500 500 500 500 500 1000 1000 1000 500 500 1000 500 1000 1000 1000 1000 1000 500 500
CAT. #
M573LPR S007LP S050LP S186LP S188LP S451LP S452LP Q004LP Q005LP Q006LP Q008LP Q041LP Q045LP Q048LP Q057LP Q058LP Q004 Q005 Q006 Q007 Q008 Q012 Q013 Q014 Q041 Q044 Q045 Q046 Q048 Q056 Q057 Q058 Q060 Q062 Q063 Q064 Q065 Q067 Q068 Q069 S080 S081 S088 S089 S103 S104 S105 S170 S171 S173
UNIT PRICE
127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 127.91 88.12 88.12 88.12 88.12 88.12 88.12 88.12 76.78 85.20 88.12 85.20 95.58 85.20 95.58 85.20 85.20 85.20 85.20 95.58 85.20 88.12 88.12 88.12 76.78 88.12 78.04 100.97 88.12 72.67 78.04 72.67 88.12 95.58 74.76
10% Disc. 2-5 Items 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 115.12 79.31 79.31 79.31 79.31 79.31 79.31 79.31 69.11 76.68 79.31 76.68 86.02 76.68 86.02 76.68 76.68 76.68 76.68 86.02 76.68 79.31 79.31 79.31 69.11 79.31 70.24 90.87 79.31 65.40 70.24 65.40 79.31 86.02 67.28
15% Disc. 6-11 Items 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 108.72 74.90 74.90 74.90 74.90 74.90 74.90 74.90 65.27 72.42 74.90 72.42 81.24 72.42 81.24 72.42 72.42 72.42 72.42 81.24 72.42 74.90 74.90 74.90 65.27 74.90 66.34 85.82 74.90 61.77 66.34 61.77 74.90 81.24 63.55
20% Disc. 25% Disc. 12-24 Items 25+Items** 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 102.33 70.50 70.50 70.50 70.50 70.50 70.50 70.50 61.43 68.16 70.50 68.16 76.46 68.16 76.46 68.16 68.16 68.16 68.16 76.46 68.16 70.50 70.50 70.50 61.43 70.50 62.43 80.78 70.50 58.14 62.43 58.14 70.50 76.46 59.81 95.93 95.93 95.93 95.93 95.93 95.93 95.93 95.93 95.93 95.93 95.93 95.93 95.93 95.93
SHEET-FEED:LPSERIES(SeePage12)SUPPLIEDINPACKAGES
SHEET-FEED, ROLL LABELS
95.93 95.93 66.09 66.09 66.09 66.09 66.09 66.09 66.09 57.59 63.90 66.09 63.90 71.68 63.90 71.68 63.90 63.90 63.90 63.90 71.68 63.90 66.09 66.09 66.09 57.59 66.09 58.53 75.73 66.09 54.50 58.53 54.50 66.09 71.68 56.07
QUALITYCONTROL:QSERIES(SeePages6-7)SUPPLIEDINROLLS
2.5" x 1.5" Black/Flour Orange
1.5" Circle Black/Fluor Green 1.5" circle Black/Flour Green 2" x 1" Black/White 2.5" x 1.5" Black/Flour Orange 1" x 0.5" 1" x 0.5" 2" x 1" 2" x 1" 0.5" circle 1" x 0.5" 0.5" circle 2" x 1" 4" x 2.5" 2.5" x 1" Black/White Black/White Black/White Black/White Red/Silver Red/Silver Red/Silver Black/Yellow Black/White Black/White
STATUS:SSERIES(SeePages3-5)SUPPLIEDINROLLS
25
** For discounts on more than 40 items please contact GMP Labeling.
LABELS
CALIBRATE BEFORE EACH USE VOID IF SEAL IS BROKEN EQUIPMENT CHECKED CALIBRATE BEFORE USE CALIBRATION NOT REQUIRED DO NOT USE: OUT OF CALIBRATION QUARANTINE QUARANTINE QUARANTINE QUARANTINE QUARANTINE MRB QUARANTINE OUT OF SERVICE MRB QUARANTINE REWORK REWORK REQUIRED RETURN TO VENDOR PREVENTATIVE MAINTENANCE PREVENTATIVE MAINTENANCE
SIZE
2" x 1" 2" x 1" 2.5" x 1.5" 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" 2.5" x 1.5" 2.5" x 1.5" 2" x 1" 2" x 1" 4" x 2.5" 2" x 3" 2" x 3" 2" x 1" 2 x 1 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" 1.5" circle 2" x 3" 2.5" x 1.5" 1.5" circle 3.5" x 1.25" 3.5" x 1.25" 2" x 0.75" 2" x 1" 2.5" x 1.5" 2" oval 2" x 0.75" 2" x 0.75" 2" x 0.75" 2" x 0.75" 2.5" x 1.5" 2" x 0.75" 2" x 0.75" 2" x 1" 2" x 1" 2" x 2" 2" x 1" 1" x 0.5"
COLOR
Red/Yellow Red/White Blue/White Red/Yellow Red/White Black/Fluor Red Red/White Red/White Red/White Black+Yellow/White Red/Yellow Black/Fluor Red Black/Flour Red Black/Flour Red Red/White Red/White Red/White Black/White Green/White Green/White Black/White Black/White Red/White Green/White Red/Yellow Green/White Green/White Green/White Green/White Black/Yellow Black/White Black/White Blue/White Black/Fluor Red Green/Yellow Green/Yellow Black/Fluor Red Green/Yellow Black/Fluor Red Black/Flour Red Green/Yellow Blue/Yellow Blue/Yellow Blue/Yellow Red/Yellow Black/White Black/White White/Blue Red/Yellow Black/Fluor Red Red/Yellow
NO. OF LABELS
1000 1000 500 1000 1000 1000 500 500 500 1000 1000 500 1000 500 500 1000 1000 500 500 500 1000 500 1000 1000 500 500 500 500 500 500 1000 500 500 1000 1000 1000 1000 1000 500 1000 1000 1000 1000 1000 500 1000 1000 1000 1000 500 1000 1000
CAT. #
S175 S177 S179 S182 S183 S185 S186 S187 S188 S189 S190 S191 S192 S193 S194 S195R S197R S199 S200 S201 S202 S203 S314R S315R S316R S318R S319R S451 S452 S511R S512 S685 S846R C075 C085 C087 C088 C090 C091 C092 C093 C094 C095 C098 C099 C102 C104 C114 C116 C118 C120
UNIT PRICE
88.12 88.12 76.78 88.12 88.12 88.12 95.58 85.20 76.78 88.12 88.12 85.20 88.12 76.78 76.78 88.12 88.12 95.58 85.20 85.20 88.12 100.97 88.12 88.12 76.78 85.20 76.78 85.20 76.78 76.78 88.12 85.20 76.78 88.12 95.88 95.88 85.49 88.12 76.78 97.05 85.49 85.49 85.49 85.49 76.78 85.49 85.49 88.12 88.12 83.92 88.12 78.04
10% Disc. 2-5 Items 79.31 79.31 69.11 79.31 79.31 79.31 86.02 76.68 69.11 79.31 79.31 76.68 79.31 69.11 69.11 79.31 79.31 86.02 76.68 76.68 79.31 90.87 79.31 79.31 69.11 76.68 69.11 76.68 69.11 69.11 79.31 76.68 69.11 79.31 86.29 86.29 76.94 79.31 69.11 87.34 76.94 76.94 76.94 76.94 69.11 76.94 76.94 79.31 79.31 75.53 79.31 70.24
15% Disc. 6-11 Items 74.90 74.90 65.27 74.90 74.90 74.90 81.24 72.42 65.27 74.90 74.90 72.42 74.90 65.27 65.27 74.90 74.90 81.24 72.42 72.42 74.90 85.82 74.90 74.90 65.27 72.42 65.27 72.42 65.27 65.27 74.90 72.42 65.27 74.90 81.49 81.49 72.67 74.90 65.27 82.49 72.67 72.67 72.67 72.67 65.77 72.67 72.67 74.90 74.90 71.33 74.90 66.34
20% Disc. 25% Disc. 12-24 Items 25+Items** 70.50 70.50 61.43 70.50 70.50 70.50 76.46 68.16 61.43 70.50 70.50 68.16 70.50 61.43 61.43 70.50 70.50 76.46 68.16 68.16 70.50 80.78 70.50 70.50 61.43 68.16 61.43 68.16 61.43 61.43 70.50 68.16 61.43 70.50 76.70 76.70 68.39 70.50 61.43 77.64 68.39 68.39 68.39 68.39 61.43 68.39 68.39 70.50 70.50 67.13 70.50 62.43 66.09 66.09 57.59 66.09 66.09 66.09 71.68 63.90 57.59 66.09 66.09 63.90 66.09 57.59 57.59 66.09 66.09 71.68 63.90 63.90 66.09 75.73 66.09 66.09 57.59 63.90 57.59 63.90 57.59 57.59 66.09 63.90 57.59 66.09 71.91 71.91 64.12 66.09 57.59 72.78 64.12 64.12 64.12 64.12 57.59 64.12 64.12 66.09 66.09 62.94 66.09 58.53
STATUS:SSERIES(SeePages3-5)SUPPLIEDINROLLS
ROLL LABELS
26
CONDITIONAL RELEASE P .M. P .M. (SELF-LAMINATING) DIRTY CLEAN TO BE CLEANED CLEANED CLEANED IN PROCESS IN PROCESS ON TEST DATE INSTALLED FILTER CHANGED STERILIZED MATERIAL SHELF LIFE FREEZE UPON ARRIVAL* REFRIGERATE UPON ARRIVAL* CAUTION: BIOHAZARD* STERILE* CAUTION: NON-STERILE* CAUTION: NON-STERILE REFRIGERATE: DO NOT FREEZE* EXPIRATION DATE* NOT FOR HUMAN USE* FOR RESEARCH ONLY* SUSPECT MATERIAL CAUTION: INVESTIGATIONAL DEVICE* CAUTION: INVESTIGATIONAL DEVICE FOR EXPORT ONLY FOR REFERENCE ONLY BIOHAZARD ALLERGEN* * Available in smaller size
CAUTION:CSERIES(SeePage10)SUPPLIEDINROLLS
To order smaller size, please specify catalog #C085s, C087s, etc. All smaller size labels have the same pricing.
LABELS
SCRAP SCRAP HAZARDOUS WASTE WASTE FOR DISPOSAL SAMPLE SAMPLE TEST SAMPLE MATERIAL CONTROL INVENTORY SAMPLED SAMPLED QA RETAIN SAMPLE R & D PRODUCT R & D PRODUCT RETURNED GOODS BUFFER SOLUTION UNIVERSAL-MATERIAL UNIVERSAL-RESEARCH UNIVERSAL C-SERIES QC STABILITY REAGENT QUARANTINE QUARANTINE IN PROCESS RELEASED RELEASED APPROVED ACCEPTED REJECTED APPROVED REJECTED RELEASED RELEASED REJECTED
SIZE
2.5" x 1.5" 4" x 2.5" 4" x 2.5" 4" x 2.5" 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" 2.5" x 1.5" 2" x 3" 2" x 3" 2" x 3" 2" x 3" 1.5" x 2.5" 2" x 3" 2" x 2" 2" x 3" 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 1" 2" x 1" 2" x 1" 2" x 2" 2" x 2"
COLOR
Red/Yellow Black/Yellow Black/Fluor Red Black/Yellow Red/Yellow Red/Yellow Red/White Red/Yellow Red/Yellow Red/Yellow Red/Yellow Red/Yellow Black/Fluor Pink Black/Flour Pink Red/Yellow Blue/White Green/White Red/White Blue/White Blue/White Blue/White Gray/White Red/White Red/White Green/White Black/Fluor Green Black/Fluor Green Black/Fluor Green Black/Fluor Green Black/Fluor Red Black/Fluor Green Black/Fluor Red Black/Fluor Green Black/Fluor Green Black/Fluor Red
NO. OF LABELS
500 500 500 500 1000 500 1000 1000 500 1000 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 1000 500 500 500 500 1000 1000 1000 500 500
CAT. #
W930 W932 W935 W936 M023 M024 M025 M032 M035 M059 M069 M079 M111 M115 M193 M213R M573R M737 M792 M793 M795 M963R S186PF S188PF S452PF Q006PF Q041PF Q045PF Q048PF Q057PF Q004CP Q005CP Q006CP Q041CP Q057CP
UNIT PRICE
76.78 95.58 95.58 95.58 88.12 97.57 88.12 88.12 98.95 97.05 85.20 76.78 85.20 76.78 85.20 85.20 85.20 85.20 76.78 85.20 83.92 85.20 93.67 89.53 89.53 108.03 89.53 89.53 89.53 89.53 108.03 108.03 108.03 89.53 89.53
10% Disc. 2-5 Items 69.11 86.02 86.02 86.02 79.31 87.81 79.31 79.31 89.06 87.34 76.68 69.11 76.68 69.11 76.68 76.68 76.68 76.68 69.11 76.68 75.53 76.68 84.30 80.58 80.58 97.22 80.58 80.58 80.58 80.58 97.22 97.22 97.22 80.58 80.58
15% Disc. 6-11 Items 65.27 81.24 81.24 81.24 74.90 82.93 74.90 74.90 84.11 82.49 72.42 65.27 72.42 65.27 72.42 72.42 72.42 72.42 65.27 72.42 71.33 72.42 79.62 76.10 76.10 91.82 76.10 76.10 76.10 76.10 91.82 91.82 91.82 76.10 76.10
20% Disc. 25% Disc. 12-24 Items 25+Items** 61.43 76.46 76.46 76.46 70.50 78.06 70.50 70.50 79.16 77.64 68.16 61.43 68.16 61.43 68.16 68.16 68.16 68.16 61.43 68.16 67.13 68.16 74.94 71.63 71.63 86.42 71.63 71.63 71.63 71.63 86.42 86.42 86.42 71.63 71.63 57.59 71.68 71.68 71.68 66.09 73.18 66.09 66.09 74.21 72.78 63.90 57.59 63.90 57.59 63.90 63.90 63.90 63.90 57.59 63.90 62.94 63.90 70.25 67.15 67.15 81.02 67.15 67.15 67.15 67.15 81.02 81.02 81.02 67.15 67.15
WASTE:WSERIES(SeePage9)SUPPLIEDINROLLS
MATERIALS:MSERIES(SeePages8-9)SUPPLIEDINROLLS
ROLL LABELS, PIN-FEED LABELS
PIN-FEED:PFSERIES(SeePage13)SUPPLIEDINPACKAGES
PIN-FEED:CPSERIES(SeePage13)SUPPLIEDINPACKAGES
SHIPPING & HANDLING

U.S. Charge $9.50 $2.75
Unit means roll or pack of labels, dispenser, or software package. First Unit: Each Additional Unit: Canada $12.50 $3.50
QUANTITY DISCOUNTS
For Design-your-own labels, standard signs, design-yourown signs and dispensers.
Quantity: 2-5 6-11 12-24 25+ = = = = 10% 15% 20% 25%
, any time. No discussi ons, no prob lems.
The GMP Labeling Gu arantee Return anyt hing
Within U.S. and Canada, goods are shipped either ground or 2nd day air. Outside U.S., goods are shipped best way. Ask for quotation.
Sales tax will be added for shipments within California.
Terms: Net 30 days on approved credit.
27
www.gmplabeling.com
6806 Fallsbrook Ct. Granite Bay, CA 95746
800-637-4487
Your head start to a Quality Management System

Time-saving Templates
GMProcedures are Standard Operating Procedures written by GMP Labeling, covering the essential elements of a Quality Management System or Quality System. The SOPs serve as prototypes or templates that will save you weeks of preparation time. Each SOP includes the procedure, one or more reporting forms, and a log book. The SOPs are organized into five compliance groups: Management Controls Design and Document Controls Corrective and Preventive Action Production and Process Controls Material Controls Recognizing the differing needs, we offer separate SOPs for Medical Device Manufacturers (MD series) and Pharmaceutical Manufacturers (PH series). For details see pages 22, 23 and www.gmprocedures.com
GMProcedures
Reporting Forms
SOPs
Log Books
Each SOP comprises a standard operating procedure, one or more reporting forms, and a log book.

Dirty: Your 2011 GMP and ISO 9000 Compliance Manual No. 21

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Dirty: Your 2011 GMP and ISO 9000 Compliance Manual No. 21

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Formats disponibles

2011

Quality Control Labels

Over 200 Styles In Stock

Save Weeks of Work

Serving Pharmaceutical and Medical Device Manufacturers Since 1987

ISO 9001 Certified

The GMP Labeling System

The GMP Labeling System

Pin-feed labels (PF series and CP series)

GMPrintsoftware to design and print labels Blank Labels

How to design your own signs

STANDARDOPERATINGPROCEDURES Pages22-23 PRICINGINFORMATION

Our Labels are Color Coded

Indicates Rejected, or potential problem with component or material

Indicates Hold or Not Yet Accepted

Indicates Accepted or Approved

Visit our website to order labels and other products on-line:

ROLL LABELS STATUS

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

Prices on page 25 & 26

1993 GMP Labeling, Inc.

VOID IF SEAL IS BROKEN

ROLL LABELS STATUS

S316R S182 S104

CALIBRATION VOID IF SEAL IS BROKEN

1992 GMP Labeling

Calibration Date: By: Next Due: ID#:

1992 GMP Labeling

P Date: .M. By: Next Due: ID#:

Cal. Date: By: Next Due: ID#:

Cal. Date: By: Next Due: ID#:

Next Due: ID#:

S080, S088 and S203 are self-laminating to protect your entries.

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

S203 2001 GMP Labeling, Inc.

S202 2001 GMP Labeling, Inc.

CALIBRATION NOT REQUIRED

1992 GMP Labeling

ROLL LABELS STATUS

Labels shown actual size. R signifies removable adhesive.

Prices on page 25 & 26

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

ROLL LABELS QUALITY CONTROL

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

ROLL LABELS QUALITY CONTROL

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

ROLL LABELS MATERIALS

M023 M213R M963R M792

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

ROLL LABELS MATERIALS/WASTE

M025 M193 M111

ROLL LABELS WASTE

W932, W935, W936 actual label size: 4 x 2.5

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

Example of smaller size.

C094* C093* C075

ROLL LABELS CAUTION

To place an order, call toll free 800-637-4487 or visit www.gmplabeling.com

Versatile Lucite Dispenser for Roll Labels

Easy accesslabels are separated from the backing as you pull

Sturdy Metal Dispensers

D125: 12(3 to 5 rolls)