Tuesday, 12 October 2021

Transfer of analytical methods


 

Chris Smith (MHRA) has written the MHRA’s thoughts on the transfer of analytical methods.

 

Common inspection deficiencies for analytical method transfer listed by MHRA are:

 

·         Equipment was not qualified for the range used in the transferred method.

·         The impact of differences in equipment was not included in the gap analysis - such as different makes and models of high performance liquid chromatography (HPLC) equipment used at transferring and receiving sites.

·         The receiving laboratory did not follow the transfer protocol.

·         The method references internal documents from the transferring laboratory which were not available at the receiving laboratory.

·         AMT was performed as a single test, on one batch of product: examples being, one single agar plate for a microbiology assay, one dissolution test, one assay test without appropriate justification.

 

·         A single strength was used to transfer methods used for multiple strengths.

 

The blog can be accessed here: https://mhrainspectorate.blog.gov.uk/2021/08/13/transfer-of-analytical-methods/

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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