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:
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.
SGS INSTITUT FRESENIUS GmbH
Phone: +49 6128 744-374