In accordance with the Freedom of Information Act, the US Food and Drug Administration (FDA) is able to make its inspection results available to the public. Conversely, inspection results of EU supervisory authorities are not easily available to the public. However, the UK Medicines & Healthcare products Regulatory Agency (MHRA) is an exception, as it recently published the 2015 GMP inspection deficiency data trend.
According to the MHRA, it has “improved the way of gathering the inspection deficiency data”. The new data trending can now allow stakeholders to identify:
- The severity and frequency by the EU GMP references
- The overall number of deficiencies by categories: Critical, Major, Other
- The high impact vs. high frequency issues
In 2015, the MHRA inspected 224 UK manufacturers and conducted 79 inspections overseas. In the top-ten list of “critical” and “major” deviations found in all inspected areas, findings regarding the quality system topped the list. This is similar to recent FDA findings.
Most Cited Deficiency Groups (Top 10)
| Ranking | Groups | Critical | Major | Others |
|---|---|---|---|---|
| 1 | Quality System | 27 | 293 | 555 |
| 2 | Complaints and Recall | 10 | 25 | 94 |
| 3 | Documentation | 9 | 138 | 372 |
| 4 | Quality Control | 4 | 26 | 136 |
| 5 | Computerised Systems | 1 | 21 | 19 |
| 6 | Production | 0 | 161 | 357 |
| 7 | Premises & Equipment | 0 | 107 | 311 |
| 8 | Validation | 0 | 93 | 128 |
| 9 | Personnel | 0 | 41 | 95 |
| 10 | Materials Management | 0 | 19 | 134 |
Most of the respective findings in chapter 1 of the EU-GMP Guidelines (Pharmaceutical Quality System) refer to 1.4, describing the pre-requisites for an appropriate Pharmaceutical Quality System, and also to 1.8, describing the Good Manufacturing Practices needed. The MHRA also focuses on ensuring “that all updates to EU GMP were captured, reviewed and implemented”.
Source: GMP Compliance news