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Harmonization of microbiological methods for pharmaceutical quality control – Are you ready? |
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Taunusstein, 13th of July 2006
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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.
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Article Life-Science Services
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Contact us - we will help you!
SGS INSTITUT FRESENIUS GmbH
Axel Wehrmann
Phone: +49 6128 744-374
Mail : axel.wehrmann@sgs.com
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