Abstract

QUALITY AUDIT: REGULATORY COMPLIANCE IN PHARMACEUTICALS

ABSTRACT

Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of organization’s quality management system and is a key element in the ISO quality system standard. Quality audit is Periodic, independent, and documented examination and verification of activities, records, processes, and other elements of a quality system to determine their conformity with the requirements of a quality standard such as USFDA and GMP. It consists of systemic reviews to verify whether or not QC duties and responsibilities are being carried out in accordance with Specifications, Sops and the GMPs. Quality audits can be an integral part of compliance or regulatory requirements. Audits can also be used for safety purposes. Quality Audit can save organizations from quality disasters.

Keywords: Quality Audit, GMP, USFDA, Quality Assuarance , Quality Control.