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2016 GMP inspection deficiency data trend

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice

Earlier this week we published the 2016 GMP inspection deficiency data trend.

The GMDP Inspectorate improved the way of gathering the inspection deficiency data with our 2015 data set. Our 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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Access our guidance on good practice for information on the inspection process and staying compliant.

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