GMP News No. 226
26 August 2002
The PIC/S document "Recommendation on Sterility Testing" (PE 001-2) provides guidance for GMP inspectors in order to "promote a consistent and thorough approach to the inspection of all aspects of sterility testing".
The statements of this Guideline refer to
sterility testing as described in the European Pharmacopoeia (Ph.Eur.
2.6.1 - Sterility) and represents thus an interpretation of the Ph.Eur.
What the text says e.g. about revalidation is very interesting. Here an excerpt:
18.104.22.168 Validation should be performed on all new products, and repeated whenever there is a change in the experimental conditions. Although it is not a pharmacopoeial requirement, it is good laboratory practice to re-validate under the current experimental conditions every 12 months. Records of validation and/or re-validation tests should be maintained in the change control procedure protocol..
You can find the unabridged document via the PIC/S homepage or directly at the following address: http://www.picscheme.org/docs/pdf/stertest.pdf