SOP – Analytical Method Validation (AMV)
SOP – Analytical Method Validation (AMV)
This SOP for Analytical Method Validation (AMV) provides a comprehensive operational guide compliant with EU GMP Annex 15, ICH Q2(R2), FDA, and EMA requirements.
Structured across 41 pages, it includes detailed procedures, validation parameter tables, acceptance criteria, protocol and report templates, operational checklists, process flowcharts, and a comparative table of regulatory requirements.
Enriched with real audit examples and best practices, it serves as a practical tool for QA, QC, Validation Experts, and Regulatory Affairs professionals to confidently face inspections and ensure full regulatory compliance.
Format: Professional PDF
Length: 41 operational pages
Updated: December 2025 – compliant with the latest GMP revisions
Available 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.