Harmonization of microbiological methods for pharmaceutical quality control – Are you ready?

With the arrival of supplement 6 of the Ph. Eur. 5 and supplement 2 of USP 29, the anticipated harmonization of microbiological inspection for non-sterile products has taken place.

SGS will extensively support you in regard to these new methods; our GMP labs evaluate these modifications internationally – also for the US market. The implementation of new methods is bindingly valid for Ph. Eur. 5.6. as of January 1st, 2007 and for USP 29 supplement 2 as of August 1st, 2007, mainly in the following areas:

  • qualification of culture media
  • growth promotion test
  • test-microorganisms
  • enrichment media
  • selective media
  • recovery rates
  • negative control
  • acceptance criteria

In order to ensure a smooth re-validation of existent methods, both methods – existent ones and new ones – are valid at the same time during a certain transition period.

You can find more information on this topic at the link below.

Article Life-Science Services

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SGS INSTITUT FRESENIUS GmbH
Axel Wehrmann
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