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1 Principle. “Quality assurance” is a broad concept that covers all factors that individually or collectively affect the quality of a product. The totality of measures taken to ensure that pharmaceutical product ucts are of the required quality for their intended use. Quality assurance therefore includes GMP and other matters, including those outside the scope of this guideline such as product design and development.
2 Appropriate quality assurance systems for the manufacture of pharmaceutical products should ensure that:
(a) pharmaceutical products designed and developed in a manner that meets the requirements of GMP and other related codes such as good laboratory practice (GLP) and good clinical practice (GCP);
(b) manufacturing and control operations are clearly specified in a written form and GMP requirements are adopted;
(c) managerial responsibilities are clearly specified in the job description;
(d) arrangements are made for the manufacture, supply and use of proper starting and packaging materials;
(e) all necessary controls of starting materials, intermediate products and bulk products and other in-process controls, calibrations and validations are carried out;
(f) the finished product is properly processed and tested according to defined procedures;
(g) pharmaceutical products are not sold or supplied before being certified by authorized persons that each production batch has been produced and controlled in accordance with the marketing authorization requirements and any other rules relating to the manufacture, control and release of pharmaceutical products;
(h) satisfactory arrangements exist to ensure as far as possible that pharmaceutical products are stored, distributed and subsequently handled by the manufacturer so that quality is maintained throughout their shelf-life;
(i) have a system for self-inspection and/or quality audit that regularly assesses the effectiveness and applicability of the quality assurance system;
(j) deviations are reported, investigated and recorded;
(k) have a mechanism for approving changes that may affect product quality;
(l) Regular assessment of drug quality should be conducted with a view to verifying the consistency of the process and ensuring its continuous improvement.
3 The manufacturer must take responsibility for the quality of the pharmaceutical products so that they are suitable for their intended use, comply with the requirements of the marketing authorization and do not put patients at risk due to insufficient safety, quality or efficacy. Achieving these quality objectives is the responsibility of senior management and requires the participation and commitment of employees in various departments and at all levels within the company, the company’s suppliers and distributors. A comprehensively designed and properly implemented system of quality assurance, incorporating GMP and quality control, must be in place to reliably achieve quality objectives. It should be fully documented and its effectiveness monitored. All parts of the quality assurance system should be adequately staffed with competent personnel and have suitable and adequate premises, equipment and facilities.
