GMP News No. 856
13 December 2006
Postponed Implementation of USP Microbiology Chapters
The EP defined a transition period for the introduction of the modified test methods until 2009.
In contrast, the USP harmonised texts would have come into force 1 August 2007.
This time frame put tremendous pressure on the pharmaceutical industry. Every company that sells its products in the US market was expected to have the new method in place by that date.
Dr Klaus Haberer, Member of the EP Expert Group1 "Microbiology" and Charter Member of the ECA Working Group on Rapid Microbiological Methods, forwarded the following information:
"The implementation of the harmonised microbiological quality USP-NF General 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 user community to allow further time to implement the new methods, and to harmonise with the implementation schedules of the European and Japanese Pharmacopoeias.
This does not change the harmonisation process, it concerns only the implementation policy in the US.
The currently official USP-NF General Chapters <61> Microbial Limit Tests and <1111> Microbiological Attributes of Non-sterile Pharmaceutical Products will remain effective until 1 May 2009.
As no transition periods are accepted by FDA, immediate implementation of the harmonised chapters would have put US-industry in a difficult position. It is recommended to US companies to validate their methods now to be ready for the implementation in 2009.
We would like to thank Dr Haberer for giving us the opportunity to
inform all ECA members about these latest developments.
To find out more about ECA's RMM Working Group please
All recent developments in microbiological quality control will be discussed in detail at ECA's Education Course "Microbiological Best Laboratory Practice", from 14-16 March 2007 in Berlin, Germany.
Dr Ulrich Herber
On behalf of ECA