Preparing Your Company for a Successful PIC/S GMP Inspection

A Pharmaceutical Inspection Co-operation Scheme (PIC/S)-led inspection is a significant event for any pharmaceutical company. These inspections are conducted by competent authorities from member countries, applying harmonized Good Manufacturing Practice (GMP) standards across the globe. Success depends on meticulous preparation, documentation accuracy, and a strong quality culture. This article presents a comprehensive guide on how companies can prepare for a PIC/S-led inspection, focusing on proactive strategies and regulatory best practices.

Understanding the Scope of a PIC/S Inspection

• PIC/S inspections may cover:
  • Manufacturing processes (API and Finished Products)
  • Quality Management Systems (QMS)
  • Validation, cleaning, and change control systems
  • Data integrity and computerized systems
  • Stability testing and sample management
• Inspections are risk-based and data-driven
• Inspectors follow harmonized formats and aide-memoires developed under PIC/S guidelines

Step 1: Review Applicable PIC/S Guidelines

• Study the current PIC/S GMP Guide:
  • Part I: Medicinal Products
  • Part II: Active Pharmaceutical Ingredients
  • Annexes 1, 11, 15 for sterile, computerized systems, and validation
• Cross-check with company SOPs, forms, and logbooks for alignment
• Note any jurisdiction-specific expectations (e.g., batch release certification in EU-based PIC/S members)

Step 2: Conduct a Mock Audit Using PIC/S Format

1. Use a PIC/S inspection checklist or aide-memoire as a template
2. Simulate the inspection route: reception to dispensing, production, QC, and warehouse
3. Involve key departments: QA, Production, QC, Engineering, IT, Regulatory Affairs
4. Document all observations and generate mock deficiency reports (critical, major, other)

Step 3: Prepare a Comprehensive Inspection Dossier

• Keep the following documentation ready and organized:
  • Site Master File
  • Validation Master Plan (VMP)
  • Cleaning validation reports
  • Batch manufacturing records (BMRs)
  • Change controls, deviations, CAPA
  • Environmental monitoring trends
  • Product Quality Reviews (PQRs)
• Use document control principles to ensure current versions are available
• Set up a centralized inspection war room with document access logs

Step 4: Train Subject Matter Experts (SMEs)

• Select SMEs for each system (e.g., QMS, validation, data integrity, cleaning)
• Prepare SME briefing documents and rehearsal Q&A sessions
• Train on:
  • How to explain SOPs confidently
  • Handling on-the-spot document requests
  • Demonstrating electronic systems and audit trails
• Ensure alignment between verbal responses and documented records

Step 5: Ensure Data Integrity Controls Are Inspection-Ready

• Inspectors will focus on:
  • Audit trails (Annex 11)
  • Access control to systems
  • Backups and recovery testing
  • ALCOA+ principles in raw data handling
• Have records from HPLC, LIMS, ERP systems ready for demonstration
• Perform data integrity risk assessments and document mitigation plans

Step 6: Confirm Equipment, Utilities, and Premises Are Inspection-Ready

• Calibrate all critical instruments with traceable certificates
• Ensure HVAC and compressed air validation reports are up to date
• Deep clean manufacturing and storage areas with logbook entries completed
• Label equipment status correctly (clean, under maintenance, in use)

Step 7: Address Historical Non-Conformances

• Review past GMP inspection reports and CAPA status
• Ensure effectiveness checks are completed for all critical/major CAPAs
• Document closure rationale clearly with supporting evidence

Step 8: Practice Professional Inspection Conduct

• Greet inspectors respectfully and provide identification badges
• Follow the predefined inspection escort plan (QA representative at all times)
• Answer only what is asked; never guess or speculate
• Take real-time notes of inspector queries and document requests

Step 9: Prepare for Inspection Closure and Follow-Up

• Capture all inspection observations systematically
• Plan for timely response:
  • Critical: within 15 days
  • Major: within 30 days
  • Other: within 60 days
• Assign owners and due dates to each CAPA
• Submit response with corrective actions, root cause analysis, and effectiveness plans

Bonus Tip: Use a PIC/S Self-Inspection SOP

• Create an internal SOP detailing:
  • Preparation steps
  • Mock inspection planning
  • Post-inspection review and CAPA closure
• Incorporate it into your QMS for ongoing readiness

Conclusion

Preparing for a PIC/S-led GMP inspection demands structured planning, multidisciplinary coordination, and a deep understanding of harmonized expectations. By proactively aligning your systems, documentation, and personnel with PIC/S requirements, your company can confidently demonstrate compliance and operational excellence. In a globally regulated industry, being inspection-ready isn’t just about passing an audit—it’s about building trust with regulators, partners, and patients alike.