ISO 9000 and 14000 Standards Significance and...

ISO 9000 and 14000 Standards Significance and Implementation in Pharmaceutical Quality Management

Author Name : Aroon Adulapuram, Neha Sri Bachu, Arshiya Naaz, Sanjeevani

DOI: https://doi.org/10.56025/IJARESM.2023.1205242741

ABSTRACT Quality of pharmaceuticals has been an issue for WHO since its establishment. In present world people are more concerned about quality, safety and efficacy of pharmaceutical products. Without assurance of meeting acceptable standards of quality, safety and efficacy of any pharmaceutical product, obviously quality of pharmaceutical product is compromised. For management of Quality, Safety and Efficacy, Quality Management System (QMS) comes in to the picture. Quality management in pharmaceutical industry is one of the most important aspect of pharmaceutical product development. It is because quality of a pharmaceutical product is directly related to the safety of consumer/ patient. For maintaining the quality, safety and efficacy companies follow several guidelines for example: USFDA, GMP, GLP, ICH, ISO etc. This review mainly focuses on ISO 9000. ISO 9000 is a widely used quality management standard across the globe. Guidelines present in ISO 9000 are intended to increase business efficiency and customer satisfaction by establishing a quality management system, increasing productivity, reducing unnecessary cost and ensuring quality and process and products. Main objective of this review is to highlight most important ISO 9000 requirements to produce an effective Quality Management System. This review also assembles ISO 9000 requirements in an effective way that will help scholars in their further research.