Pharmaceutical Manufacturing Process Audit
Complete this form to systematically audit and evaluate pharmaceutical manufacturing processes for compliance and quality.
Audit Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Hour Minutes
AM
PM
AM/PM Option
Auditor Name
*
First Name
Last Name
Plant/Facility Name
*
Manufacturing Process/Area Audited
*
Process Control Assessment
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Raw material handling
1
2
3
4
Batch records management
5
6
7
8
Process monitoring
9
10
11
12
Deviation management
13
14
15
16
Quality Management Assessment
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Quality control procedures
17
18
19
20
In-process checks
21
22
23
24
Finished product testing
25
26
27
28
Release procedures
29
30
31
32
Equipment and Maintenance
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Equipment calibration
33
34
35
36
Preventive maintenance
37
38
39
40
Cleaning validation
41
42
43
44
Equipment logs
45
46
47
48
Personnel and Training
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Training records
49
50
51
52
Competency assessment
53
54
55
56
Personal hygiene
57
58
59
60
Protective clothing
61
62
63
64
Sanitation and Hygiene
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Facility cleanliness
65
66
67
68
Pest control
69
70
71
72
Waste disposal
73
74
75
76
Cleaning schedules
77
78
79
80
Documentation and Record Keeping
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Batch records
81
82
83
84
Logbooks
85
86
87
88
Change control documentation
89
90
91
92
SOP compliance
93
94
95
96
Overall Process Compliance Rating
*
1
2
3
4
5
Audit Findings and Comments
Recommendations for Improvement
Submit Audit
Should be Empty: