VALIDATION OF ASEPTIC PROCESSES -PIC/S

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

General information 2.3.1 The basic principles and application of process validation are described in Annex 15 to the EU/PIC/S Guide to GMP and are further elaborated in PIC/S Document PI 006 (Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation) and apply also to aseptic processing. Annex I to the EU/ PIC/S Guide to GMP provides the basic requirements for the manufacture of sterile products including those aseptically processed. The Annex includes requirements, standards and recommendations, for example, for monitoring of the environment and of personnel.

.http://www.picscheme.org/pdf/26_pi007-6recommendationonasepticprocesses.pdf