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PROTOCOLREFERENCE OUTLINE
Process Validation (PPQ) Protocol
Stage 2 Process Performance Qualification protocol with CQA/CPP linkage, enhanced sampling, per-attribute acceptance criteria, and statistical evaluation. Follows the FDA 2011 lifecycle and Annex 15.
REGULATIONS MAPPED
FDA Process Validation Guidance (2011)EU GMP Annex 15
DOCUMENT TYPE
ProtocolLAST UPDATED
January 2025PURPOSE
A Stage 2 Process Performance Qualification protocol that confirms, under commercial conditions, that the process consistently produces conforming product — the heart of the lifecycle validation approach.
What's Inside
✓Process description and control strategy
✓Critical quality attributes and process parameters
✓PPQ batch sampling plan (enhanced)
✓Acceptance criteria per attribute
✓Statistical evaluation and reporting
How to Use It
1Summarise the Stage 1 control strategy and CQAs/CPPs
2Define the enhanced PPQ sampling plan
3Set per-attribute acceptance criteria
4Execute the PPQ batches under commercial conditions
5Evaluate statistically and define continued verification
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose, Scope, and Process Overview
2Lifecycle Context (Stage 1 → 2 → 3)
3CQA and CPP Linkage
4Enhanced Sampling Plan
5Per-Attribute Acceptance Criteria
6Statistical Evaluation Approach
7Execution and Batch Records
8Conclusion and Release to Stage 3
REGULATORY CONTEXT
The FDA Process Validation guidance (2011) lifecycle and EU GMP Annex 15 frame Stage 2 PPQ. This protocol structures the enhanced sampling and statistical evidence expected before routine production.