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Introduction to PIC/S: Structure, Functioning, Documents and Aide-Memoires

Introduction to PIC/S: Structure, Functioning, Documents and Aide-Memoires

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The most comprehensive guide for QA, QP, RA, Site Managers, Validation and anyone who needs to understand PIC/S — the organisation that harmonizes GMP inspections globally.
It clearly explains how PIC/S works, which documents it uses (PI Guides, Aide-Memoires, SOPs), how they influence inspections, and how a company can become truly “PIC/S-ready”.

This guide covers, in a practical and operational way, everything needed to work, export and succeed in audits according to PIC/S standards: from the functioning of the PIC/S Committee to the Working Groups, the relationship with EU GMP and FDA, and the inspection checklists used for audit preparation.

Inside you will find:
🌍 What PIC/S is and why it is essential for companies exporting to Europe, Asia, USA, Australia and Canada (Chap. 1).
🏛️ PIC/S Structure: Committee, Secretariat, Working Groups, Sub-Committee on Training, Inspectorate Network (Chap. 2).
📄 Official PIC/S Documents: PI Guides, Aide-Memoires, Procedural Documents, Training Materials — what they are and how to use them (Chap. 3).
🔎 PIC/S vs EU GMP vs FDA: differences, overlaps and stricter requirements (Chap. 4).
🚀 Impact on exporting companies: implications for QA, QP, RA, Manufacturing, Validation and Supplier Qualification (Chap. 5).
🛡️ How to prepare for PIC/S audits: Aide-Memoire, 7-step roadmap, common mistakes and effective CAPAs (Chap. 6).
📋 Operational checklists and templates: PIC/S readiness checklist, Aide-Memoire checklist, supplier compliance, Data Integrity PI 041, gap assessment, audit preparation plan (Chap. 7–8).

Perfect for QA Managers, QP, RA Specialists, Site Managers, Validation/CSV teams, Supplier Qualification and all functions involved in international audits.

Format: Professional PDF
Pages: 119
Updated: December 2025
Languages: ITA – ENG

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Main references for this guide PIC/S PE 009 · PIC/S guidance and aide-mémoires · EU GMP
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