Quality assurance means the sum total of the organized arrangements made with the objective of ensuring that medicines and Health Products are of the quality required for their intended use. The system of quality assurance for the manufacture of medicines and health products should ensure that
- Medicine and health products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice
- Production and control operations are clearly specified and GMP adopted;
- Managerial responsibilities are clearly specified;
- Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials
- All necessary controls on intermediate products, and any other in-process controls and validations are carried out;
- Finished product is correctly processed and checked, according to the defined procedures;
- Alternative medicine and health products are not sold or supplied before an authorized person has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicine and health products;
- Satisfactory arrangements exist to ensure, as far as possible, that the medicine and health products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life
- There is a procedure for self inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system
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