Tim
Sandle and Clare Leavy have reviewed the latest report from the MHRA looking at
the major regulatory findings for 2016. In the review the key trends are broken
down into ‘hot topics’ and the key findings discussed.
For the past three
years, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has
produced information summarizing key inspectorate trends. With each successive
year the level of detail provide with the headline trends has been made more
comprehensive. The most recent review (2016) is notable for the appearance of
‘sterility assurance’ in the top ten key categories of inspectorate trends. Not
only does this subject appear on the list for the first time, it occupies the
number two spot.
This
includes: management, water systems, aseptic processing, microbiology
laboratories, aseptic connections, personnel gowning, data integrity, staff training
and cleaning and disinfection.
The
reference is:
Sandle,
T. and Leavy, C. (2017) A focus on regulatory trends: MHRA annual deficiency
review, Pharmig News, Issue 69, pp2-5
Posted by Dr. Tim Sandle