Introduction to PIC/S: Structure, Functioning, Documents and Aide-Memoires
Introduction to PIC/S: Structure, Functioning, Documents and Aide-Memoires
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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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.