A Comprehensive Guide to GxP Compliance in Regulated Industries
Abstract: GxP compliance plays a crucial role in regulated industries such as in the pharmaceutical sector, where ensuring the safety, efficacy, and quality of products is a top priority. With the increasing adoption of digital technologies and Enterprise Resource Planning (ERP) systems like SAP, organizations now face added complexity in maintaining compliance while trying to streamline and improve their operations. This article provides an in - depth look at GxP in the context of pharmaceutical manufacturing, including its history, the regulatory bodies involved, and the important considerations organizations should take when undergoing ERP transformations. It also discusses typical challenges faced by organizations when implementing GxP process and explores future trends that are shaping the industry in light of Industry 4.0.
Keywords: GxP compliance, pharmaceutical sector, ERP systems, regulatory bodies, Industry 4.0
How to Cite?: Rohit Singhal, "A Comprehensive Guide to GxP Compliance in Regulated Industries", Volume 12 Issue 5, May 2023, International Journal of Science and Research (IJSR), Pages: 2704-2707, https://www.ijsr.net/getabstract.php?paperid=SR24923123325, DOI: https://dx.doi.org/10.21275/SR24923123325