Operational Guide to GMP Cleaning Validation
Operational Guide to GMP Cleaning Validation
Cleaning Validation is a fundamental GMP requirement to prevent cross-contamination and ensure product safety, and it is one of the areas most frequently cited during FDA, EMA, and PIC/S audits.
This operational guide clearly, structurally, and pragmatically explains how to design, implement, and maintain a Cleaning Validation program compliant with EU GMP (Annex 15), EMA HBEL/PDE guidelines, and international inspection expectations—translating regulatory requirements into concrete, audit-ready activities.
Beyond regulatory interpretation, the guide provides operational processes, decision criteria, and practical tools to confidently manage audits and inspections in both sterile and non-sterile environments.
What you will find inside:
📘 GMP regulatory framework explained in operational terms (FDA, EMA, PIC/S)
✅ Lifecycle approach to Cleaning Validation (design, qualification, maintenance)
🧮 MACO calculation (dose-based, HBEL/PDE, microbiological)
⚙️ Worst-case selection and definition of cleaning processes
🧪 Sampling methods (swab, rinse, visual) and analytical requirements
📋 Operational checklists, GMP templates, and audit readiness tools
⚠️ Common mistakes and strategies to prevent inspection findings
A practical guide designed for QA, Validation, Manufacturing, QC, and Regulatory Affairs professionals involved in managing and validating cleaning operations.
Format: Professional PDF
Length: 160 pages
Updated: January 2026
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.