Académique Documents
Professionnel Documents
Culture Documents
QUALITY ASSURANCE
S/N
1
TITLE
Good Laboratory Practice
2.
3.
4.
5.
6.
Product Complaints
8.
Batch Review
9.
Product Recall
10.
11.
12.
13.
14.
15.
16.
Documentation
17.
Batch Documentation
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
Validation Exercise
34.
Validation Committee
35.
Analytical Validation
36.
Cleaning Validation
37.
Retrospective Validation
38.
39.
Stability Testing
40.
41.
42.
Environment
43.
44.
45.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
WAREHOUSE
S/N
TITLE
1.
2.
3.
4.
5.
6.
7.
8.
Safety In Warehouse
9.
10.
11.
TITLE
Facilities in the Locker Room
2.
3.
4.
5.
Preventing Contamination
6.
Maintenance of Equipment
7.
8.
Batch Identification
9.
10.
Yield
11.
Coating Operations
12.
Process Validation
13.
Process Change
14.
Re-processing
15.
16.
Product Change
17.
18.
19.
Weighing Process
20.
Material Flow
21.
22.
23.
Cleaning of oven
24.
25.
26.
27
28
29
30
31
32
33
34
35
Packaging Plan
36
37
38
Mistake/Mix-Up/Contamination
39
Printing Exercise
40
41
42
43
44
GENERAL
S/N
1.
TITLE
Guidelines for Writing Standard Operating Procedure
2.
G.M.P Committee
3.
4.
Training
5.
6.
Follow-up/Refresher Courses
7.
8.
Drug Safety
9.
10.
11.
12.
13.
14.
Destruction of Materials
15.
16.
Manufacturing Prescription
17.
Suppliers Audit
18.
19.
20.
21.
22.
23.
Handling Deviations
24.
25.
Returned Goods
26.
Training on SOP
27.
28.
Product Recall
29.
Product Complaints
30.
ENGINEERING
S/N
TITLE
1.
2.
Preventive Maintenance
3.
4.
Lubrication
5.
6.
7.
8.
9.
10.
11.
Maintenance equipments
12.
Boiler Operations
13.
LIST OF REQUIREMENTS
1.
Personnel Details
2.
Organogram
3.
List of Products
4.
5.
6.
Quality Policy
7.
8.
Evidence of Training
9.
10.
11.
12.
13.
10
INTRODUCTION:
This Quality Audit is performed on behalf of the Pharmaceutical Manufacturers Group of
the Manufacturers Association of Nigeria (PMG-MAN). As an active member of the
Group, we believe that every member company will maintain at least the minimum
standard of the requirements of current Good Manufacturing Practices (GMP) and Good
Laboratory Practices (GLP).
The planning and effective performance of this audit is aimed at ensuring these minimum
standards.
The non-conformities detected during this audit must be corrected within the agreed time
frame.
11
Product Lines:
Date of Audit:
Auditors:
Audited Persons/Units:
12
GENERAL IMPRESSION
13
PRIORITY ACTIONS
14
15
RATING
MEANING
INTERPRETATION
Excellent
Item/Area/System/Knowledge is Superior
Adequate
Item/Area/System/Knowledge Meets
Basic Minimum Requirements
Poor
Item/Area/System/Knowledge is weak
and not up to Acceptable Standard
Unacceptable
Item/Area/System/Knowledge is
Missing or of such Nature to Warrant
Serious Quality/Compliance Concerns
16
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
SECURITY
1.
2.
3.
4.
5.
6.
T I
N
0
REMARKS
N/A
17
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
N
0
REMARKS
N/A
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
18
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
17.
18.
19.
20.
21.
22.
23.
24.
25.
TITLE
T I
N
0
REMARKS
N/A
26.
27.
28.
29.
30.
31.
32.
19
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
FINISHED GOODS WAREHOUSE
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
T I
N
0
REMARKS
N/A
20
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA - LIQUIDS
WEIGHING
1.
2.
3.
4.
T I
N
0
REMARKS
N/A
5.
6.
7.
8.
9.
10.
11.
12.
21
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
MIXING
13.
14.
15.
16.
17.
18.
19.
T I
N
0
REMARKS
N/A
FILLING
20.
21.
22.
23.
24.
22
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
26.
27.
28.
29.
30.
31.
T I
N
0
REMARKS
N/A
23
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA - TABLETTING
1.
2.
4.
5.
6.
7.
8.
9.
11.
12.
13.
T I
N
0
REMARKS
N/A
3.
10.
24
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA
14.
15.
16.
17.
18.
T I
N
0
REMARKS
N/A
19.
20.
21.
22.
23.
24.
25.
26.
27.
25
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
T I
N
0
REMARKS
N/A
26
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA
38.
39
40.
41.
T I
N
0
REMARKS
N/A
27
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PACKAGING - BLISTERING
1.
2.
3.
5.
6.
7.
8.
9.
10.
12.
13.
14.
15.
16.
17.
18.
T I
N
0
REMARKS
N/A
4.
11.
28
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA
19.
20.
T I
N
0
REMARKS
N/A
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
29
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
ENGINEERING (WORKSHOP)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
T I
N
0
REMARKS
N/A
30
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
N
0
REMARKS
N/A
GENERAL SERVICE
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
31
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
N
0
REMARKS
N/A
CANTEEN
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
32
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
N
0
REMARKS
N/A
33
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
14.
15.
TITLE
T I
17.
18.
19.
20.
21.
22.
24.
25.
26.
27.
28.
REMARKS
N/A
16.
23.
34
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
N
0
REMARKS
N/A
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
35
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
45.
46.
47.
48.
49.
51.
53.
54.
55.
56.
57.
REMARKS
N/A
50.
52.
36
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
58.
59.
60.
61.
62.
63.
64.
66.
67.
68.
70.
71.
72.
73.
REMARKS
N/A
65.
69.
37
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
74.
75.
76.
77.
78
79
80
81
82.
83.
N
0
REMARKS
N/A
- Process
- Machines and equipment?
Is a retrospective validation carried out on a
periodic basis on a particular product?
Does retrospective validation include trend
analysis?
38
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
MICROBIOLOGICAL TESTING
84.
85.
86.
87.
88.
89.
90.
91.
T I
N
0
REMARKS
N/A
92.
93.
94.
95.
96.
39
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
97
98.
99.
100.
101.
102
103
104
105
T I
N
0
REMARKS
N/A
40
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
N
0
REMARKS
N/A
MANAGEMENT
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
41
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
N
0
REMARKS
N/A
42
AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
T I
N
0
REMARKS
N/A
43