Considerations on Regulatory Quality Control in Pharmaceutical Industry

Abstract

With the development of pharmaceutical fields, the quality control of the pharmaceutical industry gets more and more attention. The aims of pharmaceutical industry are manufacturing high quality medicines, identifying the safety of products and assessing the efficacy of medicines. Pharmaceutical industry has to achieve the manufacturing standard which is regulated by the authorities. The industry or company requires to adhere the medicines principles such as Pharmacopoeia, Good manufacturing practice (GMP) or International Council on Harmonisation (ICH) and manufacturing medical products should follow the Standard Operation Procedure (SOP). In order to build a good medical quality supervision system, industry needs to control the monitoring of every step of medicines in production process from many different perspectives. Also, doing the sampling inspection for products to make sure the characterization of medicines could help to achieve the standard. Therefore, this paper will focus on the importance and advantages of regulatory control of medicines, research on the factors that affect the medicines quality in pharmaceutical industry and puts forward some effective ways to improve the quality of manufacturing.