Sterility Testing: PIC/S Document PE 001-2 with Recommendations for GMP Inspectors

GMP News No. 226

GMP News
26 August 2002

Sterility Testing
PIC/S Document PE 001-2 with Recommendations for GMP Inspectors

In the past years, the recommendations issued by PIC/S have gained in importance. The PIC/S Guide Validation Master Plan, IQ, OQ, PQ, Cleaning (PI 006-1) has served as a basis for the new Annex 15. The other Guides, too, like e.g. Recommendation on Guidance on Parametric Release (PI 005-1) or Validation of aseptic processing (PI 007-1), are increasingly considered to be important. So it is worth while having a look at the document "Recommendation on Sterility Testing" (PE 001-2), even though it was published some time ago.

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. Monograph.
Some of the topics discussed in chapters of their own are:

  • Personnel training
  • Sterility test facilities
  • Cleaning, sanitisation and disinfection
  • Environmental monitoring
  • Sterility test details
    - Sampling
    - Test methodology
    - Media types and manufacture
    - Incubation period
    - Negative test controls
    - Negative product controls
    - Positive controls
  • Documentation of the results
  • Interpretation and repeat tests

What the text says e.g. about revalidation is very interesting. Here an excerpt: 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:

Dr Günter Brendelberger
CONCEPT Heidelberg

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