PIC/S PI Documents, Aide-Memoires and Operational Guidelines: How to Read, Interpret and Apply Them
PIC/S PI Documents, Aide-Memoires and Operational Guidelines: How to Read, Interpret and Apply Them
The ultimate guide to understanding and applying the PIC/S documents used by inspectors during GMP audits.
Perfect for QA, QP, RA, Validation, Sterile Manufacturing and Compliance teams who want to speak the inspector’s language and be truly audit-ready.
Inside you will find:
📘 Complete explanation of the key PIC/S PI documents
PI 006 (Quality Systems & Validation), PI 009 (Sterile Manufacturing), PI 041 (Data Integrity), PI 043 (ATMP) — with operational interpretation and links to EU GMP, Annex 1, ICH Q9/Q10.
📝 Aide-Memoires: how to really use them
How to read them, map them, integrate them into the PQS, and how inspectors use them to guide inspections.
🔍 What inspectors look for
Typical questions, critical points, recurring errors, PQS weakness signals and real expectations during EMA/FDA/PIC/S audits.
🧪 Complete case studies
Data integrity failures, unsuccessful media fills, systemic PQS deviations, ATMP issues — real cases explained step by step.
✔️ Operational checklists and templates
Checklists for PI 006, PI 009, PI 041, PI 043, a comprehensive inspection mega-checklist, PIC/S-style CAPA templates, mapping tools and PQS integration resources.
Perfect for anyone preparing for an inspection, building a stronger quality system, or trying to understand what inspectors will truly evaluate.
Format: Professional PDF
Pages: 98
Updated: December 2025
Languages: ITA – ENG
DOWNLOAD A PREVIEW OF THE GUIDE
Couldn't load pickup availability
HAVE QUESTIONS? CHECK OUT OUR FAQS
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.