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GMP Published

Recommendations on VMP, Installation and Operational Qualification, Process Validation, Cleaning Validation

This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: the Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation by PIC/S.

Organizations:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Topics:
Qualification & Validation

Version Timeline

Chronological release history

PI 006-4

Version milestone

Published

Publication Date

Aug 1, 2026

Effective Date

Oct 1, 2026

Main updates: - A more "whole" recommendation document on validation and qualification, - Focus on risk-based activities and scientific justification, - Fewer exact recommendations (like 3 process validation batches), more focus on the manufacturer's own judgement of what is acceptable, - From 29 to 49 pages, - Added transport verification, packaging validation, utilities qualification, data integrity.
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PI 006-3

Version milestone

Published

Publication Date

Sep 25, 2007

Effective Date

Sep 1, 2001

Main updates: This is the current document, in-force until October 01, 2026.
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