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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