How to Become PIC/S-Ready in Your Organization
How to Prepare for a PIC/S Audit Step by Step
Phase 1 – Understand the PIC/S Structure
- Central Committee
- Secretariat
- Working Groups
- Training Sub-Committee
- Inspectorate Network
👉 This explains why inspectors are aligned with each other.
Phase 2 – Map PIC/S Documents
Main categories:
- PI (Guidance)
- Aide-Mémoire
- Procedural Documents
- Training Materials
Phase 3 – Use Aide-Mémoire as Checklists
Aide-Mémoire become:
- Internal audit tools
- Realistic inspection simulations
- Basis for gap assessments
Phase 4 – Implement PIC/S-Oriented CAPAs
Example:
Data Integrity gap → CAPAs on audit trails, backups, and user access
Phase 5 – Update the PQS in Line with ICH Q10
PIC/S directly impacts:
- Change control
- Deviation management
- Training
- Data governance
Watch out for…
- Outdated SOPs
- Purely theoretical training
- Unrealistic internal audits
How to Manage a PIC/S Non-Conformity
- Root cause analysis
- Immediate corrective action
- Systemic preventive action
- Effectiveness verification
Common Mistakes
- Thinking PIC/S is only “for exports”
- Ignoring the Working Groups
- Not using official checklists
Concise Operational Checklist
- PIC/S gap assessment
- Mapped Aide-Mémoire
- Targeted training
- Tracked CAPAs
- Updated PQS
Use Case
A company failed to map PI 041 → FDA Data Integrity deviation → 6-month export delay.