As per WHO guideline “Quality Assurance of Pharmaceuticals” Volume 2:
Quality management in the drug industry
In the drug industry at large, quality management is usually defined as the aspect of management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are:
- An appropriate infrastructure or “Quality System”, encompassing the organizational structure, procedures, processes and resources;
- Systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality.
The totality of these actions is termed “Quality Assurance”.
Within an organization, quality assurance serves as a management tool.
The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.
“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.
Functions of Quality Assurance:
The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
- 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);
- Production and control operations are clearly specified in a written form and GMP requirements are adopted;
- Managerial responsibilities are clearly specified in job descriptions;
- Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
- All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out;
- The finished product is correctly processed and checked, according to the defined procedures;
- Pharmaceutical products are not sold or supplied before the authorized persons 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;
- 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;
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.