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GMP Deficiency Data- A trend published by MHRA

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

Following are the observations of the report:

MHRA wants industries to perform their self-inspection and continuous process improvement in order to attain avoids deficiency in the final data. According to the MHRA, continual efforts towards maintaining the data integrity and clarity would bring about clear and concise data trends.

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

Overall, this report cited many facets of data collection which will improve the further documentation and computerized system generated process flow.



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