Pharmaceutical Compliance Assessment Form
Please complete this assessment to help us evaluate pharmaceutical compliance practices.
Which area of pharmaceutical operations are you assessing?
*
Please Select
Manufacturing
Quality Control
Research & Development
Distribution
Regulatory Affairs
Other
Are all required Standard Operating Procedures (SOPs) up to date and accessible?
*
Yes
No
Partially
Which compliance areas have documented non-conformities in the last 12 months? (Select all that apply)
*
Documentation
Equipment Maintenance
Training Records
Deviation Reporting
None
Other
Rate the overall effectiveness of your compliance training program.
*
1
2
3
4
5
How frequently are internal audits conducted?
*
Monthly
Quarterly
Annually
Less than annually
Please indicate your level of agreement with the following statements regarding compliance culture.
*
Rows
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
Management demonstrates commitment to compliance.
1
2
3
4
5
Staff are encouraged to report potential violations.
6
7
8
9
10
Compliance resources are readily available.
11
12
13
14
15
Which external guidelines or standards does your department primarily follow?
*
FDA (21 CFR)
EMA (EU GMP)
ICH Guidelines
WHO GMP
Other
How would you rate the clarity of documentation for compliance procedures?
*
Unclear
1
2
3
4
Very Clear
5
1 is Unclear, 5 is Very Clear
Is there a process in place for reporting and investigating deviations?
*
Yes
No
In Progress
Additional comments or suggestions regarding pharmaceutical compliance:
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