News about GMP/cGMP

16.05.2017

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