Quality Risk Management in Pharmaceutical Industry
Quality Risk Management in Pharmaceutical Industry
P. Hatwar,Manali C. Asare,Jiterdra A. Kubde,Ravindra L. bakal
TLDR
The basic principles, elements, and legal framework that control QMS in the pharmaceutical industry are examined in this paper and Good Manufacturing Practices (GMP), risk management, GLP, TQM, QC and QA, maintenance, GLP and GMP, and auditing procedures are highlighted.
Abstract
The pharmaceutical sector functions under a highly regulated environment where patient safety and product quality are of utmost importance. Maintaining product consistency, ensuring regulatory compliance, and promoting continuous improvement all depend on a strong quality management system (QRM). The basic principles, elements, and legal framework that control QMS in the pharmaceutical industry are examined in this paper. Good Manufacturing Practices (GMP), risk management, GLP, TQM, QC and QA, maintenance, GLP and GMP, and auditing procedures are among the essential components that are highlighted.