European authorities' viewpoint on validation deficiencies

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

End of April an article reported about the New Analysis of GMP Inspections by MHRA for the year 2016. 

Amongst other things, this publication addresses deficiencies concerning validation/qualification. Deficiencies in those areas hold the 5th place of most frequently mentioned deficiencies. In the year before that, validation only held the 8th place, although qualification deficiencies weren't included at the time; they hadn't been mentioned, at any rate.

The deficiencies concerning the sections of Annex 15 of the European GMP guidelines are shown in table form, divided into critical, major and other deficiencies. The number of critical deficiencies is relatively low. In view of major deficiencies, the chapter cleaning validation comes in first place with over 20 citations, followed by deficiencies in organisation and planning, documentation (and validation master plan) and Quality System. Most "other deficiencies" can also be found in the chapters organisation and planning, documentation (and validation master plan) and Quality System.

The report also lists some exemplary findings: there was no change control process implemented, for example.  There was no or only an insufficient user requirement specification. The validation master plan was not specific enough (no consideration of utilities, process validation and cleaning validation). The cleaning validation hasn't been performed. Processing parameter ranges haven't been covered by the validation. There was no general statement that validation batches are releasable for commercial sale.

For more details please also see the complete MHRA GMP Inspection Deficiency Data Trend 2016.