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);
(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 section 10.6) 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.
1.3 The manufacturer must assume responsibility for the quality of the phar-maceutical 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.