Interesting Analysis of GMP Inspections published

Due to the Freedom of Information Act (FOI), the FDA makes their inspection results available to the public. More rarely, however, the public gets informed about inspection results of EU supervisory authorities. The U.K. Medicines & Healthcare Products Regulatory Agency (MHRA) is a positive exception from this rule. Now, the 2015 GMP inspection deficiency data trend has been published by MHRA's GMDP Inspectorate.

According to the MHRA they have "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 has inspected 224 UK manufacturers and performed 79 inspections overseas. In the top-ten list of "critical" and "major" deviations found in all inspected areas, findings regarding the quality system rank first (see illustration 1). This is similar to recent FDA findings.

 

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. And MHRA focuses also on ensuring "that all updates to EU GMP were captured, reviewed and implemented":

"There was no formal process on-site to ensure the updates to regulatory requirements were considered for impact on to the site quality system; for example Chapter 3, 5 and Annex 15". And a lot of observations were made in the handling of deviations and CAPA, as can be seen in the examples given in the report.

The report "MHRA GMP Inspection Deficiency Data Trend 2015" lists examples for all relevant chapters and annexes of the EU-GMP Guidelines, allowing stakeholders to "perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement".

When it comes to Annex 16 for example (Certification by a Qualified Person and Batch Release), a Qualified Person (QP) can get a view on what is expected. And this shows that the days of a QP being expected to sit in an office only checking batch records and certifying batches are gone. The QP should have a clear vision of what level of information and involvement is necessary to do the job. Here are some highlights:

  • The QP did not have visibility of the overall Risk Assessments
  • The QP has not reviewed the Quality Impact Assessment in the course of batch certification
  • The QP was not keeping up to date with site systems

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