GMP IN PHARMACEUTICAL MANUFACTURING: CURRENT BEST PRACTICES
Krishnanand Gangaram Chimne, *Sakshi Omprakash Jaju, Dr. Sunil S. Jaybhaye, Bhagwat Sudhakar Gabale and Vikas Santosh Dongare
ABSTRACT
Good Manufacturing Practices (GMP) play a pivotal role in ensuring the production of high-quality pharmaceutical products that are safe, effective, and consistent. This publication provides an overview of the current best practices in pharmaceutical manufacturing, emphasizing the key principles of GMP and their application in the production environment. It examines the critical components of GMP, including personnel training, facility design, equipment maintenance, raw material control, and quality assurance systems, all of which are essential for maintaining compliance with regulatory standards. The paper also highlights the importance of risk management, validation processes, and continuous improvement in meeting evolving industry demands and ensuring consumer safety. With the increasing complexity of pharmaceutical products and manufacturing technologies, this publication discusses emerging trends and challenges in GMP, focusing on the integration of modern technologies such as automation, data integrity, and advanced quality systems.
Keywords: Good Manufacturing Practice, GMP, Pharmaceutical Inspection, Food and Drug Administration.
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