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The 50-Question Pharma Compliance Checklist

Answer these 50 questions before your next FDA, EU GMP, or national authority inspection. Identify gaps your regulators will look for - and fix them first.

Covers CSV, QA, data integrity, training, and CAPA
Aligned with FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q10
Print-ready format - use it with your QA team today
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The 50-Question Checklist

Use this checklist with your QA team before any regulatory inspection. Print it, check off each item, and identify your highest-risk gaps.

Documentation & SOPs (Q1–Q10)

1
All SOPs are current, approved, and version-controlled
2
SOPs reflect actual current practice (no gaps between document and reality)
3
All SOP revisions have a documented change history
4
Training on current SOP versions is complete for all relevant staff
5
SOPs are readily retrievable during an inspection
6
Batch records are complete, accurate, and contemporaneous
7
Raw data is retained alongside processed results
8
All forms and templates referenced in SOPs are current versions
9
Document retention periods are defined and being followed
10
Superseded SOP versions are archived and not available for use

🔍 Data Integrity (Q11–Q20)

11
Audit trails are enabled in all GxP computerised systems
12
Audit trail reviews are performed regularly and documented
13
No shared logins exist in any GxP system
14
System access controls are reviewed periodically
15
All GxP data entries are attributable to the individual who made them
16
Original data is never deleted - only superseded with a clear audit trail
17
Electronic records are backed up and backup integrity is tested
18
Staff are trained on data integrity principles and requirements
19
Out-of-specification (OOS) investigation procedures are in place and followed
20
No paper records are reconstructed after the fact

💻 Computerised Systems (Q21–Q30)

21
All GxP computerised systems have a current validation status
22
Validation files are complete, signed, and accessible
23
Change control process covers vendor-initiated software updates
24
Computer system validation SOPs are current
25
Periodic reviews of validated systems are documented
26
User access provisioning and de-provisioning is controlled and documented
27
System downtime and contingency procedures are documented
28
All systems have a GAMP 5 category assessment on file
29
Supplier/vendor qualification is complete for all GxP SaaS providers
30
Data migration validations are complete for any recent system changes

🏭 Equipment & Facilities (Q31–Q36)

31
All critical equipment has a current qualification status (IQ/OQ/PQ)
32
Equipment calibration records are within schedule
33
Preventive maintenance is documented and up to date
34
Equipment logbooks are maintained and current
35
Facility qualification is current for all GMP areas
36
Temperature and environmental monitoring records are complete

👥 Training (Q37–Q42)

37
Training matrix is current and reflects all active SOPs
38
All staff training records are complete and up to date
39
Training is documented before task performance (not retroactively)
40
Training effectiveness assessments are conducted and recorded
41
New SOP training is completed before the SOP goes into effect
42
Contractor and visitor training records are maintained

⚡ Deviations & CAPA (Q43–Q50)

43
All open deviations have documented status and are not overdue
44
CAPA root cause investigations are documented with evidence
45
CAPA effectiveness checks are completed and documented
46
No CAPAs have been open for more than 6 months without justification
47
Complaint handling procedures are in place and documented
48
Change control records are complete for all recent changes
49
Trend analysis of deviations is performed periodically
50
Previous inspection CAPAs are all closed with documented evidence

Found gaps? PHARPRO can help you close them before your next inspection.

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