Monday, 30 October 2017

Review of MHRA GMP deficiencies


Tim Sandle has written a review for GMP Review looking at recent MHRA inspectorate findings relating to sterility assurance.

Reading and reviewing findings from regulatory inspections can help an organisation to develop best practices and to understand the current ‘hot topics’ in relation to regulatory inspections. Such reviews also allow an organisation to appreciate inspectorate trends and assess the impact on their sites. The latest MHRA GMP Inspection Deficiency Data Trend 2016 is notable for the number of findings under the umbrella term ‘sterility assurance’. This is a new deficiency group so this article examines a selection of these findings.

The reference is:

Sandle, T. (2017) MHRA annual deficiency review highlights sterility assurance issues, GMP Review, 16 92): 4-7

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle