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QA is a broad concept, covering all factors, which individually or collectively affect the quality of a product. The sum total of organized measures aimed at ensuring that pharmaceutical products are of the required quality for their intended use. QA, therefore, encompasses other factors such as GMP and product design and development.
A suitable QA system for manufacturing pharmaceutical products should ensure that:
1. Pharmaceutical products are designed and developed in a manner that takes into account the requirements of GMP and other related codes such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
2. Manufacturing and control operations are clearly specified in a written form and GMP requirements are adopted.
3. Arrangements are made for preparation, supply and use of proper starting and packaging materials.
4. All necessary controls of starting materials, intermediate products and bulk products and other in-process controls, calibrations and validations are carried out.
5. Pharmaceutical products are not sold or supplied before the finished product has been properly processed and tested, according to defined procedures, certified by authorized persons that each production batch has been produced and controlled in accordance with marketing authorization requirements and any other regulations. Relevant to the manufacture, regulation and release of pharmaceutical products.
6. 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;
7. Deviations are reported, investigated and recorded.
8. Regular evaluation of the quality of pharmaceutical products should be conducted with the aim of verifying the consistency of the process and ensuring its continuous improvement.
