Key personnel responsible for supervising the production and quality unit(s) for pharmaceutical products should possess the qualifications of a scientific education and practical experience required by national legislation.
Their education should include the study of an appropriate combination of:
(a) chemistry (analytical or organic) or biochemistry;
(b) chemical engineering;
(c) microbiology;
(d) pharmaceutical sciences and technology;
(e) pharmacology and toxicology;
(f) physiology;
(g) other related sciences.
They should also have adequate practical experience in the manufacture and QA of pharmaceutical products. In order to gain such experience, a preparatory period may be required, during which they should perform their duties under professional guidance. The scientific education and practical experience of experts should be such as to enable them to exercise independent professional judgement, based on the application of scientific principles and understanding to the practical problems enered in the manufacture and QC of pharmaceutical products.
