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MHRA 2015 GMP Inspection Deficiency Data Trend


2015 GMP inspection deficiency data trend

Mark Birse, 12 January 2017 — Compliance matters, Good manufacturing practice

The 2015 GMP  inspection deficiency data trend has been published by MHRA. 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.

Courtesy: https://mhrainspectorate.blog.gov.uk/2017/01/12/2015-gmp-inspection-deficiency-data-trend/