Main Article Content
Naman Vohra
Department of Pharmacy, St. Soldier Institution of Pharmacy, Lidhran Campus, Behind NIT(R.E.C), Jalandhar -Amritsar By Pass Nh-1, Jalandhar 144011, Punjab, India
Rajesh Kumar
Department of Pharmacy, St. Soldier Institution of Pharmacy, Lidhran Campus, Behind NIT(R.E.C), Jalandhar -Amritsar By Pass Nh-1, Jalandhar 144011, Punjab, India
Himani Rana
Department of Pharmacy, St. Soldier Institution of Pharmacy, Lidhran Campus, Behind NIT(R.E.C), Jalandhar -Amritsar By Pass Nh-1, Jalandhar 144011, Punjab, India
Amar Pal Singh
Department of Pharmacy, St. Soldier Institution of Pharmacy, Lidhran Campus, Behind NIT(R.E.C), Jalandhar -Amritsar By Pass Nh-1, Jalandhar 144011, Punjab, India
Ajeet Pal Singh
Department of Pharmacy, St. Soldier Institution of Pharmacy, Lidhran Campus, Behind NIT(R.E.C), Jalandhar -Amritsar By Pass Nh-1, Jalandhar 144011, Punjab, India
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. Qualitymanagement in pharmaceutical industry is one of the most important aspects of pharmaceutical product development. It isbecause 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, and 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 establishingaquality management system, increasing productivity, reducing unnecessary costand ensuring quality and process andproducts.
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 theirfurther research.