info@biomedres.us   +1 (720) 414-3554   600 Third Avenue, 2nd floor, New York - 10016, USA
ISSN: 2574 -1241
Impact Factor 0.548

Review ArticleOpen Access

Quality Management System in Drug Industry: A Review

Volume 2 - Issue 1

Priyambada Pandey*1 and Goyal Anju2

  • Author Information Open or Close
    • 1M. Pharma Research Scholar, B.N. Institute of Pharmaceutical Sciences, India
    • 2Professor & HOD, Department of Pharmaceutical Quality Assurance, BN Institute of Pharmaceutical Sciences, India

    *Corresponding author: Priyambada Pandey, M. Pharma Research Scholar, B.N. Institute of Pharmaceutical Sciences, Udaipur, India, Tel: 7073250880; Email: priyambadapandey93@gmail.com

Received: January 04, 2018;   Published: January 11, 2018

DOI: 10.26717/BJSTR.2018.02.000653

Full Text PDF

To view the Full Article   Peer-reviewed Article PDF

Abstract

Quality of medicines means meeting the required specifications. Quality management in pharmaceutical industries, is an important subject because the drugs / or pharmaceutical products are directly delivered to the customers body system, thus identity, purity safety and ultimately appropriate quality of product are strongly essential. ICH Guidelines are established with a view to bring uniformity in the products worldwide. It helps in export and import of drug products worldwide. Maintaining quality in the products is a complex process and needs to take into account various guidelines like GMP, GLP and many more. There is a Quality assurance department in all the Pharma industries whose job is to look if all the required guidelines are being followed in the industries or not. Quality auditing is the process through which they check internally or externally and ensure everything is running right. The present paper focuses on the Quality management system in the Drug industry and their elements.

Keywords: Quality Assurance; Quality Management system; GMP; GLP; Drug Industry

Abstract| Introduction| Quality Management System (QMS)| International Conference on Harmonization [6,7]| Pharmaceutical Quality Management System [11]| Conclusion| References|