(2003; 148 pages)
1. Quality assurance
1.1 Principle. “Quality assurance” is a wide-ranging concept covering 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 pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.
1.2 The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
(a) pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP)1 and good clinical practice (GCP);
1 This is a code governing the testing of chemicals to obtain data on their properties and ensuring safety with respect to human health and the environment. It is different from that described in “Good laboratory practices in governmental drug control laboratories” in the Thirtieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 748, 1987, Annex 1).
(b) production and control operations are clearly specified in a written form and GMP requirements are adopted;
(c) managerial responsibilities are clearly specified in job descriptions;
(d) arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
(e) all necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out;
(f) the finished product is correctly processed and checked, according to the defined procedures;
(g) pharmaceutical products are not sold or supplied before the authorized persons (see also sections 9.11 & 9.12) have 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 pharmaceutical products;
(h) satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life;
(i) there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system;
(j) deviations are reported, investigated and recorded;
(k) there is a system for approving changes that may have an impact on product quality;
(l) regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
1.3 The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the company, the company’s suppliers, and the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of the quality assurance system should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment, and facilities.