Rx REPORT

MHRA Publishes 2015 GMP Inspection Deficiency Data

On January 11, 2017, MHRA published the 2015 GMP inspection deficiency data trend. The top 10 most cited deficiency groups were:

  1. Quality System
  2. Complaints and Recall
  3. Documentation
  4. Quality Control
  5. Computerized Systems
  6. Production
  7. Premises & Equipment
  8. Validation
  9. Personnel
  10. Materials Management

The GMDP Inspectorate has improved the way of gathering the inspection deficiency data for 2015. The new data trending can 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

The purpose of publishing the inspection deficiency data is to allow stakeholders to perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement. Deficiency examples are included for each relevant chapter and annex for information.

Note: This is the data set for dosage form only.

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