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Quality Assurance and GLP - PharmaFacts
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Quality Assurance and GLP

Guidances - OECD Guidances

A quality assurance programme is defined in the Revised OECD Principles of Good Laboratory Practice as "a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice" [Section I.2.2(8)]. The responsibilities of the management of a test facility include ensuring "that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is  being performed in compliance with these Principles of Good Laboratory Practice" [Section II.1.1(2f)]. In addition the test facility management should ensure "that the Study Director has made the approved study plan available to the Quality Assurance personnel" [Section II.1.1(2j)] and the responsibility of the Study Director should include ensuring "that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study" [Section II.1.2(2b)]. The test facility management should also ensure that “for a multi-site study that clear lines” of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel [Section II.1.1(2o)].

QUALITY_ASSURANCE_AND_GLP.pdf