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K. Santhosh Kumar and T.M. Pramod Kumar*


This article mainly describes the purpose of c-GMP inspection and the process held in two different countries, United states (USFDA) and Singapore (HSA). CGMP refers to the Current Good Manufacturing Practice regulations. CGMPs provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. The goal of an audit is to express an opinion on the person, organization, system etc. in question, under evaluation based on work done on a test basis. Inspection’s are performed to ascertain the validity and reliability of information; also to provide an assessment of a system's internal control. As already mentioned, GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws. However, at the same time the GMP rules are more or less internationally harmonized such as e.g. the ICH Q7 Guidelines representing the “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” being adopted by the regulatory bodies of the European Union (EU), Japan and USA (see also further GMP guidelines as referenced at the end of this article below). A company that makes medications today must be able to prove that it does so with absolute reliability, under optimal secure conditions and with extreme uniformity to allow for exact reproduction.

Keywords: Auditing, Regulatory aspect, FDA, Audit program, GMP components, Importance, Purpose and procedure of an audit.

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