Details on GC Inspection Findings

Anon
13/12/2020 23:14

"Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP" do provide the overview of the GCP Inspection findings. However, is there any specific publication availble which provides in-depth view on the processes that have resulted in GCP findings. For eg, Statistical analysis is mentioned in the above EMA publication. However, it is not know where the findings were eg generation of SAP, Validation, Generation of Statistical Output, QC process, filing of documentation.

Colin Wilsher
14/12/2020 08:18

I hope others have some ideas. 》 As far as I know, EMA don't publish details. MHRA do publish details of their critical findings. FDA of course publish Waring letters. 》 all will change when CTR comes in to effect and there is more transparency

Juergen Kaetzler
14/12/2020 10:05

As far as I know, EMA publish a summary of their inspection in the annual reports, for example: https://www.ema.europa.eu/en/documents/annual-report/annual-report-good-clinical-practice-inspectors-working-group-2018_en.pdf >> GMP non-compliance is reported in the respective database: http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do >> As Colin mentioned: with the EU-CTR many things will change also transparency concerning GCP deviations and inspection findings.

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