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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:
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Personnel training
-
Sterility test facilities
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Cleaning, sanitisation and disinfection
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Environmental monitoring
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Sterility test details
- Sampling
- Test methodology
- Media types and manufacture
- Incubation period
- Negative test controls
- Negative product controls
- Positive controls
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Documentation of the results
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Interpretation and repeat tests
What the text says e.g. about revalidation
is very interesting. Here an excerpt:
11.6.2.4 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
Author:
Dr Günter Brendelberger
CONCEPT Heidelberg
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