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GMP News No. 856
13 December 2006
Postponed Implementation of USPMicrobiology Chapters
The EP defined a transition period for the introduction of themodified test methods until 2009.
In contrast, the USP harmonised texts would have come into force 1August 2007.
This time frame put tremendous pressure on the pharmaceuticalindustry. Every company that sells its products in the US market wasexpected to have the new method in place by that date.
Dr Klaus Haberer, Member of the EP Expert Group1 "Microbiology" andCharter Member of the ECA Working Group on Rapid MicrobiologicalMethods, forwarded the following information:
"The implementation of the harmonised microbiological quality USP-NFGeneral Chapters originally scheduled to be effective on 1 August 2007,has been postponed until 1 May 2009.
The postponement is in response to requests received from the usercommunity to allow further time to implement the new methods, and toharmonise with the implementation schedules of the European and JapanesePharmacopoeias.
This does not change the harmonisation process, it concerns only theimplementation policy in the US.
The currently official USP-NF General Chapters Microbial LimitTests and Microbiological Attributes of Non-sterilePharmaceutical Products will remain effective until 1 May 2009.
As no transition periods are accepted by FDA, immediateimplementation of the harmonised chapters would have put US-industry ina difficult position. It is recommended to US companies to validatetheir methods now to be ready for the implementation in 2009.
We would like to thank Dr Haberer for giving us the opportunity toinform all ECA members about these latest developments.
Dr Ulrich Herber
On behalf of ECA