1Department of Pharmaceutical Quality Assurance, Divine College of Pharmacy, Satana, Nashik, Maharashtra, 423301, India, Affiliated with Savitribai Phule Pune University
2Department of Pharmaceutical Chemistry, Divine College of Pharmacy, Satana, Nashik, Maharashtra, 423301, India, Affiliated with Savitribai Phule Pune University
A quality management system (QMS) must be the first step in any quality and compliance approach. In this review, the QMS sector will be evaluated in relation to the pharmaceutical industry. In order to accomplish this goal, the guidelines Q10 (pharmaceutical quality system) and Q9 (quality risk management) made by the ICH are put into practice. These rules significantly contribute to maintaining the product’s quality throughout the entire process, from manufacturing to marketing. The study and evaluation of the quality management system (QMS) in these industries are conducted using a variety of case studies or examples of successful risk management in the pharmaceutical business. This review’s primary area of interest is the body of research on how businesses really handle risk.
Quality risk management, Quality management system, Pharmaceutical quality system, QMS, ICH, Q10, Q9
