PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007
Titel:
PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007
Kurztitel:
PI 006-3
Internet:
Herkunft/Verlag:
Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Dokumentenart:
Recommendation
Inhalt:
This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows:
Validation Master Plan
Installation and Operational Qualification
Non-Sterile Process Validation
Cleaning Validation
The four Recommendations comprising this document define general principles pertaining to each of the topics.