Guidance for Industry — Process Validation: General Principles and Practices
Revises FDA's process validation framework from a three-batch endpoint approach to a lifecycle-based model with three stages: Process Design, Process Qualification, and Continued Process Verification.
All manufacturers of finished drug products under 21 CFR Parts 210/211. Also considered best practice reference for API manufacturers and biologics.
- 01Stage 1: Process Design — identify CQAs, CPPs, and their ranges; design the commercial process
- 02Stage 2: Process Qualification — demonstrate the process performs at commercial scale
- 03Stage 3: Continued Process Verification — statistical process control and trend monitoring
- 04Validation protocols must define acceptance criteria before execution
- 05Risk-based approach to determining validation scope and sampling plans
- 06Change control triggers for re-validation or additional validation activities
Current version issued January 2011. No revisions. Considered the global reference for lifecycle process validation alongside ICH Q8.
FDA Process Validation Guidance (2011): frequently asked questions
Quick answers to common questions about FDA Process Validation Guidance (2011).
What is FDA Process Validation Guidance (2011)?
FDA Process Validation Guidance (2011) — Guidance for Industry — Process Validation: General Principles and Practices — is a guidance issued by the Food and Drug Administration (United States). Revises FDA's process validation framework from a three-batch endpoint approach to a lifecycle-based model with three stages: Process Design, Process Qualification, and Continued Process Verification.
Who does FDA Process Validation Guidance (2011) apply to?
All manufacturers of finished drug products under 21 CFR Parts 210/211. Also considered best practice reference for API manufacturers and biologics.
What are the key requirements of FDA Process Validation Guidance (2011)?
FDA Process Validation Guidance (2011) requires, among other things: Stage 1: Process Design — identify CQAs, CPPs, and their ranges; design the commercial process; Stage 2: Process Qualification — demonstrate the process performs at commercial scale; Stage 3: Continued Process Verification — statistical process control and trend monitoring; Validation protocols must define acceptance criteria before execution.
When was FDA Process Validation Guidance (2011) last updated?
The current version of FDA Process Validation Guidance (2011) dates from January 2011. Current version issued January 2011. No revisions. Considered the global reference for lifecycle process validation alongside ICH Q8.
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