Bioequivalence and Bioavailability Forum • No GCP “certificate” for BE-centers issued by EU countries

No GCP “certificate” for BE-centers issued by EU countries [GxP / QC / QA]

posted by Dr_Dan – Germany, 2012-10-08 15:07 (4996 d 07:32 ago) – Posting: # 9333
Views: 8,007

Dear all
I know that no “GCP certificates” for BE-centers are issued by EU RAs, however, some (east or south EU) RAs ask for GCP certificates for studies (study centres) included in the dossier for marketing authorization application although there is no legal base for this. A GCP inspection is study related, focuses on conditions, practices or processes that affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data and is not a system audit (EMEA/INS/GCP/197226/2005).
However, to my knowledge there had been some discussions at EMA whether to issue GCP certificates or not but I do not know the outcome. Someone else?
Kind regards
Dan

Edit: Document linked. [Helmut]

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Kind regards and have a nice day
Dr_Dan

Complete thread:

Facility inspection by UKMHRA/EU cakhatri 2012-10-07 11:30
- Facility inspection by UKMHRA/EU ElMaestro 2012-10-07 12:50
  - Facility inspection by UKMHRA/EU cakhatri 2012-10-09 06:57
- No GCP “certificate” for BE-centers issued by EU countries Helmut 2012-10-07 13:21
  - No GCP “certificate” for BE-centers issued by EU countriesDr_Dan 2012-10-08 13:07
    - (Bad) experiences… Helmut 2012-10-08 13:56
    - No GCP “certificate” for BE-centers issued by EU countries ElMaestro 2012-10-08 16:22
  - No GCP “certificate” for BE-centers issued by EU countries cakhatri 2012-10-09 07:16