Tepnel offers single harmonised non-sterile microbiology methods
Tepnel Pharmaceutical Services is now able to offer the harmonised methods for non-sterile microbiological testing, making it quicker, more cost effective and easier for manufacturers to comply with the new regulations for European, US and Japanese Pharmacopoeias.
Tepnel Pharmaceutical Services is now able to offer the harmonised methods for non-sterile microbiological testing, making it quicker, more cost effective and easier for manufacturers to comply with the new regulations for European, US and Japanese Pharmacopoeias.
All substances with pharmacopoeial monographs are required to comply with USP/JP/Ph. Eur. with the new reference methods.
Non-monograph substances and monograph products to USP/JP also need to be compliant.
Non-monograph substances and monograph products to Ph. Eur. must be compliant by January 2010.
The harmonised method for specified micro-organisms also includes a new specific test organism (Candida albicans) and allows for variable sample quantity and changed limits depending on factors such as batch size and intended use.
Tepnel says the harmonised approach improves microbiological testing by changing to more modern media formulations. These improvements help drive efficiency by reducing the need for duplicate testing, which can streamline raw material, active ingredient or finished product release.
Tepnel has completed the method establishment for both parts of the Microbiological Examination of Non-Sterile Products tests, namely the Microbial Enumeration Tests and the Test for Specified Micro-Organisms. This methodology has been developed in line with the guidance from the commissioners of the British, European, US and Japanese Pharmacopoeias, which provide a single harmonised testing method.
