An Examination of the GAMP-5 Guidelines as They Relate to GxP Regulated Computerized Systems - Sponsored Whitepaper

An Examination of the GAMP-5 Guidelines as They Relate to GxP Regulated Computerized Systems
Sponsored by:
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BatchMaster Software, Inc.
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The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced by the FDA, which focuses on an integrated approach of good science and good engineering practices to bring about innovation in pharmaceutical industries. We will discuss collaboration between the FDA and different regulatory agencies of the world, especially in quality-related areas and the development of harmonized scientific standards for assessment of drug product quality. Cooperation of the FDA with the Pharmaceutical Inspection Scheme (PIC/S) has resulted in the “Guidance on Good Practices for Computerized system in regulated GxP environment”, where “GxP regulated Computerized systems” are defined as the systems that keep information related to Good Manufacturing Practice (GMP),Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), to ensure that computerized systems are fit for the intended use and compliant with applicable regulations. According to these guidelines a computer-related system is considered to be GxP if it impacts, or has the potential to impact, product quality (safety, quality, integrity, purity or potency). It is also a GxP system if it performs a function specifically governed by cGMP regulations.
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