How to Prepare for a PIC/S Inspection – Operational Audit-Ready Guide
How to Prepare for a PIC/S Inspection – Operational Audit-Ready Guide
The most comprehensive guide for QA, QP, RA, Manufacturing, QC and Site Managers who need to prepare practically and effectively for a PIC/S inspection.
It explains, in an operational and concrete way, what inspectors expect, which documents must be ready, which areas receive the most attention, and which mistakes most frequently lead to observations and non-conformities.
With an audit-ready approach, the guide provides a clear roadmap to structure pre-audit preparation, manage the inspection day by day, and organize responses, CAPAs and post-inspection follow-up. All of this is based on current PIC/S guidelines, official Aide-Memoires and international best practices.
Inside you will find:
📝 7-step roadmap to prepare for a PIC/S inspection: documentation, training, data integrity, layout, manufacturing, laboratory, technical services.
🔍 What PIC/S inspectors ask for: typical questions, required evidence and critical focus areas according to Aide-Memoires (QA, QC, Manufacturing, Contamination Control, Data Integrity).
🏭 How to organize an effective inspection room: document flows, roles, SMEs, logbooks, request tracking.
⚠️ Common mistakes to avoid during an inspection: inconsistencies in batch records, open deviations, outdated training, data-integrity gaps.
📂 Essential documents to have ready: PQS, critical SOPs, trends, KPIs, CCS, audit trails, change control, CAPA, validations.
🛡️ Strategies for responding to inspectors: how to present evidence, handle difficult questions, protect the GMP perimeter and avoid escalation.
📋 Operational checklists: PIC/S readiness checklist, Aide-Memoire checklist, document readiness, typical observations and CAPA templates.
Perfect for QA Managers, QP, RA Specialists, Manufacturing Supervisors, QC Managers, Validation/CSV Specialists and all teams involved in international audits.
Format: Professional PDF
Pages: 98
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.