PIC/S Audit: What Inspectors Actually Verify

Introduction

A PIC/S audit is not a standard audit. It is a global, shared, and harmonized inspection with cross-border consequences.

Regulatory Analysis

PIC/S integrates:

• EU GMP
• ICH Q9 – Q10
• ISO 17025 (laboratories)
• Data Integrity (PI 041)

What Inspectors Look For

• Data governance
• Contamination control
• Effective training
• Documented validation
• A robust PQS

How to Avoid Critical Deviations

• Internal audits using Aide-Mémoire
• Systematic use of risk management
• Structured data review
• PIC/S-integrated SOPs

Audit Readiness

Essential Documents:

• Training matrix
• Deviation log
• Risk assessment
• Validation Master Plan
• Data Integrity policy
• CAPA tracking

Typical Mistake

• Mistake: backups not tested
• Corrective action: backup validation + restore testing

Conclusion

PIC/S is the standard governing the audits of the future.
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