Statements of GCP and GLP compliance [GxP / QC / QA]

posted by Ohlbe – France, 2019-01-23 00:29 (678 d 08:57 ago) – Posting: # 19799
Views: 3,721

Dear ElMaestro,

» Assessment report template from CMD(h) [...] Is there a statement on GLP compliance?

» Is the template based on a semantic brilliancy - Perhaps they truly want compliance with GLP and GCP for bioanalysis but for some reason or other the CRO isn't supposed to actually spell out the latter?

I think it is actually very simple:
- OECD GLP, section II, § 1.2.2.h, require the study director to sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these principles of good laboratory practice. Consequence: the bioanalytical report needs to include a statement of GLP compliance signed by the study director.
- GCP does not require anybody (sponsor, investigator or whoever, let alone anybody at labs) to sign any kind of statement of GCP compliance.
- AFAIK, the only reference text applicable in the EU that mentions a statement of compliance with GCP is ICH E3 on the structure and contents of clinical trial reports, according to which (section 1) the title page of a study report should include a statement indicating whether the study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents. Not the bioanalytical report, the cover page of the study report, to which the bioanalytical report is appended.

So IMHO the reason why the assessment report template does not include a reference to a GCP compliance statement in the bioanalytical report is simple: as far as I know, there is no legal requirement to have one :crying:

Regards
Ohlbe

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