The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
Recommendations on Sterility Testing (PI 0012-3) Sept 2007
Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Content:
This document provides guidance for GMP inspectors in order to promote a consistent and thorough approach to the inspection of all aspects of sterilty testing.