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.
