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News about GMP/cGMP

2017-05-16

British MHRA Published Trends on GMP Deficiency Data

The GMDP Inspectorate of the British MHRA (Medicines & Healthcare products Regulatory Agency) has published its yearly report on inspection deficiency findings. This time the method of gathering the data has been improved, thus introducing new data trending.

 

This will allow industries to identify:

  • The severities and frequencies by the EU GMP references
  • The overall number of deficiencies by categories: Critical, Major, Other
  • The high impact vs high frequency issues

According to the MHRA, the purpose for publishing the inspection deficiency data was to allow industries to perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement.

242 UK inspections and 82 overseas inspections were conducted in 2016 (324 inspections in total)

Here are the Top 10 most cited deficiency groups 2016:

Ranking Groups Critical Major Others
1 Quality System 38 449 772
2 Sterility Assurance 34 190 162
3 Production 20 191 543
4 Complaints and Recall 11 80 110
5 Qualification/Validation 10 123 232
6 Premises & Equipment 9 113 464
7 Computerised Systems 9 44 120
8 Personnel 8 42 150
9 Documentation 2 166 646
10 Quality Control 2 42 192















If you are interested in reading the full report, please click here.

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