Validation Master Plan (VMP) GMP: How to Govern Validation and Defend It in EMA, AIFA, FDA and PIC/S Audits

The Validation Master Plan is one of the very first documents an inspector asks for during an audit.
Not because it is “formally required on paper”, but because it immediately reveals whether a company truly controls validation or is simply reacting to it.

In practice, however, many VMPs are static documents: written years ago, never updated, and disconnected from risk assessment, change control and the validation lifecycle.
During an audit, this turns into difficult questions, uncertainty and avoidable findings.

This guide is based on real experience from EMA, AIFA, FDA and PIC/S inspections and is designed for QA Managers, Validation Managers, Engineering and QPs who need to use the VMP to make decisions, not just file it away.

The Real Problem

In day-to-day operations, this is what almost always happens:

• The VMP is written once and then forgotten
• It is unclear what is in scope and what is not
• Everything is “validated the same way”, without a real risk-based approach
• Every change creates uncertainty: do we need to revalidate or not?
• During audits, the VMP no longer reflects the real facility
• Validation documents are not aligned with each other

The result?
Slow decisions, documents rewritten multiple times, and weak answers in front of inspectors.

The Concrete Benefits You Get

• Drastically reduce the time needed to structure or revise a VMP
• Make fast, defensible decisions on scope, risk and revalidation
• Avoid over-validation and under-validation
• Know exactly what to say — and what to show — during audits
• Turn the VMP into a governance tool, not an inspection risk

No theoretical benefits.
Just time saved and risk reduced.

What the Guide Contains

This is not a regulatory explanation.
It is an operational, audit-ready guide, based on real cases. It includes:

• Complete structure of a modern VMP
• Clear scope definition (inclusions / exclusions with rationale)
• A truly applied risk-based approach (decision matrices and criteria)
• Validation strategy by category
  (facilities, processes, cleaning, utilities, CSV/CSA, methods)
• Integration with lifecycle, change control and ICH Q12
• Practical management of requalification and maintenance of the validated state
• Real linkage with SOPs, inventories, trackers and PQR
• How to present and defend the VMP during an audit
• Real inspection red flags — and how to avoid them

Each section is written to be used immediately.

Why Buy This Guide?

You already have the regulations.
What is usually missing is:

• Practical interpretation
• Decision-making criteria
• Clear linkage between documents
• Audit defensibility

This guide:

• Has already done the interpretation work for you
• Tells you when to validate, when not to, and why
• Prevents starting from scratch every time
• Saves you days of work, not hours

It costs far less than the time it saves you during the very first VMP review.

Who This Guide Is For — and Who It Is Not

Ideal for:

• QA Managers
• Validation Managers
• Qualified Persons (QP)
• Engineering & Technical Managers
• CSV / CSA Responsible Roles
• Companies subject to EMA, FDA or PIC/S audits

Not suitable if:

• You are looking for an academic explanation of GMP
• You just want a “fill-in-the-blank” template without understanding the decisions
• You do not work in a regulated GxP environment

This guide is built on real inspections, not theoretical interpretations.
It is aligned with EMA, FDA and PIC/S expectations and designed with a risk-based, lifecycle-driven and audit-ready approach.

If your current VMP does not make you feel confident during an audit, this guide is what you are missing.

Product Details

• Format: Professional PDF
• Length: 62 pages
• Updated: February 2026
• Languages: ITA – ENG

DOWNLOAD A PREVIEW OF THE GUIDE