European Authority's Inspection Findings in the Area Validation/Qualification

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.

In the top 10 of MHRA's inspection deficiencies 2015, the topic validation occupies rank 8. However, no critical deficiency was found. Most "major" deficiencies concerned the validation report and changes to the validation plans.

Regarding the topic qualification, the MHRA presents the following exemplary deficiencies:

  • Lack of design phase (DQ, URS) for new equipment 
  • Qualification documents provided by equipment suppliers were not integrated into the company's pharmaceutical quality system to ensure appropriate review.
  • The use of suppliers' documentation for the qualification was criticised a second time: the OQ protocol for an HVAC system obtained from a supplier hadn't been compared and checked with the company's requirements prior to its approval.
  • One heat tunnel equipment hadn't been fully qualified in the OQ. 

With regard to the topic cleaning validation, the MHRA criticised that:

  • The effective removal of organic compounds couldn't be assured.
  • The effectiveness of sprayballs used for vessel cleaning hadn't been demonstrated nor controlled.
  • The permitted limits for carryover of organic molecules had neither been set nor risk assessed.
  • No swab samples had been taken - in particular from difficult to clean areas where other methods or determining residues may not be effective.
  • There was no scientific rationale to support the selection of products used for the cleaning validation.

Concerning process validation, the MHRA gave the following examples deficiencies:

  • The performance and process validation activities didn't include any assessment of all critical parameters (e.g. tablet dimensions and embossing).
  • Not every aspect of manufacturing was covered by process validation (e.g. the use of small coating pans as opposed to the validated automated system).
  • Validation batches were released before process qualification had been completed.

It is interesting to note that the MHRA criticised twice that the companies inspected had no formal processes for implementing changes in the GMP regulations. Annex 15 - which became applicable as revised version in October 2015 - had been explicitly mentioned once.

You can find the complete MHRA's report on GMDP findings on their website.

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