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Harmonised EP, USP and IP regulations on monitoring microbiological quality

Regulations on examining microbiological quality were harmonised in the European, US and Japanese Pharmacopoeias and implemented in Europe on January 1, 2007 with the 6th supplement of the 5th edition of the European Pharmacopoeia (Supplement 5.6).

The aim is for the previous and the new harmonised methods to co-exist at first to make the transition possible. The harmonised text will presumably apply in Europe from January 2009 and in the USA from May 2009 onwards.

Revised regulations 5.1.4, 2.6.12 and 2.6.13 in the European Pharmacopoeia (Ph. Eur.) contain numerous amendments compared to the methods in previous European Pharmacopoeias. Amendments to acceptance criteria, incubation conditions and culture media are of particular significance to pharmaceutical companies.

These amendments mean that:

• product specifications need to be examined and adapted if necessary
• microbiological tests for existing products need to be revalidated and methods may need to be adapted
• method validation is generally prescribed for each product

UFAG LABORATORIEN has implemented the new methods and will be happy to support you during your implementation. We can provide you with comprehensive and competent advice and can help you with validation tasks.

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