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GMP Gepubliceerd

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.

Organisaties:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Onderwerpen:
Qualification & Validation

Versietijdlijn

Chronologische releasegeschiedenis

PI 006-4

Versiemijlpaal

Gepubliceerd

Publicatiedatum

1 aug 2026

Ingangsdatum

1 okt 2026

Belangrijkste 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

Versiemijlpaal

Gepubliceerd

Publicatiedatum

25 sep 2007

Ingangsdatum

1 sep 2001

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