The two weeks assessment by a team of experts from Europe will review NDA’s inspectorate quality management systems, quality control laboratory and pharmacovigilance systems. The experts will also observe NDA GMP inspectors conduct GMP inspections in order to establish their competence and technical knowledge.
NDA is grateful to Dr Catherine Oakes and Dr. Loice Kikwai, a team of international consultants with vast experience in the pharmaceutical regulatory arena, for having agreed to perform an independent self-assessment of the NDA inspectorate function in preparation for PIC/S accession.
