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
Posted by Dr. Tim Sandle