Journal of Developing Drugs
Open Access

Good practice for the management of quality audits conducted by regulatory audits

4^th International Summit on GMP, GCP & Quality Control

October 26-28, 2015 Hyderabad, India

D Ravali Reddy, Shashi Kumar, Sanjeev Kumar and A Sambasiva Rao

Sri Indu Institute of Pharmacy, India

Posters-Accepted Abstracts: J Develop Drugs

Abstract :

Regulatory audits possibly developed to promote conference with the activation regulations and standards, which collectively prescribed and acceptable level of activation process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled determine, whether the quality system confirms to specified requirements and effectiveness of the implemented system. Mainly discuss â�?�?good practice for the management of quality audit conducted by regulatory auditâ�?. These audits are carried out by regulatory bodies against relevant system for manufacture and supply of pharmaceutical products. National Regulatory bodies such as Medicine Control Agency (MCA) in the UK and FDA in USA with centralized procedure are statutorily responsible for carrying out such audits. They may be unannounced regulatory body from other countries in which products are sold may also audit companies.

Biography :

Email: desaniravalireddy@gmail.com