This will allow industries to identify:
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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