Quality Assurance

Quality Assurance

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. QA therefore includes GMP and other factors such as product design and development

QA=Product design + GMP + QC + quality goal activities

Criteria of Quality

Safety

Potency

Efficacy

Stability

Acceptability

Regulatory compliance

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 Good manufacturing practices for pharmaceutical products, Part One. In: WHO Expert Committee on specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).

Associated codes such as those of good laboratory practice (GLP) 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 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.

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).

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.