Pharmaceutical Quality Assurance 19 1.4 LEGAL ASPECTS Personnel related Legal Aspects are covered in regulatory literature, only by M.C.C. South Africa guidelines, W.H.O. and Schedule M of D and C Act of India. Let us see briefly what these guidelines say about this. w @ @ Schedule M of D and C Act India says that: (@ ‘The manufacturing shall be conducted under the direct supervision of ‘Competent Technical Staff with prescribed qualifications and practical ‘experience in the relevant dosage form and/or active pharmaceutical products. Gi) ‘The testing shall be conducted under the direct supervision of Competent ‘Technical Staff, who shall be whole time employees of the licensee. W.H.O. guidelines say that : (@ Key personnel responsible for supervising the manufacture and quality control ‘of pharmaceutical products should possess the qualifications of a scientific education and practical experience required by national legislation. It further states that, the seientific education and practieal experience of experts should be such as to enable them to exercise independent professional judgment based on the application of scientifie prineiples understanding to the practical problems encountered in manufacture and quality control of pharmaceutical produet. M.C.C. South Africa says that : (i) ‘The Company and the Managing Director (who must be a pharmacist residing in the republie) must be registered with Pharmacy Council Gi) All directors must confirm that they will abide by the pharmacy councils ethical rules. ii) Pharmaceutical operations must be conducted under the constant personal supervision of pharmacists whose name is displayed over the main entrance (iv) Certain duties and responsibilities must be performed by pharmacists e.g, manipulation, preparation or compounding of medicines, manufacturing, furnishing of advice with regard to medicines, distribution and sale of medicines. (v) Other legal requirements cover : + Labelling of medicines, including package inserts. + Records and registers for scheduled medicines. + Sale of medicines to only registered and approved customers + Registration of medicines with the M.C.C, + Adherance to standards. * Reporting of adverse reactions and technical errors. + Advertising of medicines. * Carrying and supply of professional samples. (vi) Legislation also covers detailed procedures for handling of narcotics and psychotropic drugs. III O <