PIC/S Recommendation on Sterility Testing Revised

GMP News No. 278

GMP News
13 January 2003
 

PIC/S Recommendation
on Sterility Testing Revised

 
The "Recommendation on Sterility Testing" was published by PIC/S under the new number PI 012-1 in November 2002. This document substitutes for the former Guideline PE 001-2 of 17 April 2000.
This Guideline is meant to provide guidance in the training of the PIC/S GMP inspectors and in the preparation of inspections. It is the aim of this Guideline to make a consistent and thorough approach in all aspects of the inspection of sterility testing possible.

The revision of this document concerns above all formal aspects, as e.g. changes in the introduction, purpose and scope, a modified page numbering and an updated list of references.

Among the updated references, there is the new PIC/S document PI 014-1 of 24 June 2002, which makes recommendations concerning isolators used for aseptic processing and sterility testing.

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG

You can download the "Draft Recommendation on Isolators Used for Aseptic Processing and Sterility Testing" by clicking here. The "Recommendation on Sterility Testing" can be found here.

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