Amendment status not verified — confirm the current text below against the official source.
Quality Assuranc:–This is a wide-ranging concept concerning all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that products are of the quality required for their intended use. 14.1 The system of quality assurance appropriate to the manufacture of pharmaceutical products shall ensure that: – (a) the pharmaceutical products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practices (hereinafter referred as GMP) and other associated codes such as those of Good Laboratory Practices (hereinafter referred as GLP) and Good Clinical Practices (hereinafter referred as GCP); (b) adequate arrangements are made for manufacture, supply and use of the correct starting and packaging materials. (c) adequate controls on starting materials, intermediate products and bulk products and other in-process controls, calibrations, and validations are carried out. (d) the finished product is correctly processed and checked in accordance with established procedures; (e) the pharmaceutical products are not released for sale or supplied before authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the label claim and any other provisions relevant to production, control and release of pharmaceutical products.