Bioequivalence and Bioavailability Forum • Auditing of CRO QA (Quality Assurance)

vivekanand
☆

India,
2013-05-25 08:21
(4767 d 12:54 ago)

Posting: # 10653
Views: 5,738

Auditing of CRO QA (Quality Assurance) [GxP / QC / QA]

Dear All

In a CRO generally QA(Quality Assurance)is an independent body shall audit the site in repect to project based and system and facility based.

QA shall audit all the departments(like Clinic,bioanalytical,Statistical) in the site for system and facility wise.

My question is who shall audit the same CRO QA for system and facility audit.

Regards
G.Balavivekanand

Edit: Category changed. [Helmut]

sarada06884 ☆ India, 2013-05-29 10:27 (4763 d 10:48 ago) @ vivekanand Posting: # 10680 Views: 4,510	Auditing of CRO QA (Quality Assurance) Post reply
	Dear Mr. Vivekanand, Since there would be a bias if QA is audited internally, it is recommended that QA be audited by a cross functional department or by a external/ third party auditor. This has to be well defined in the SOP. This is for the same reason as to why QA is kept independent of the operational departments (In order to avoid bias). Regards Srinivas