AUDITING ON REGULATORY SIX SYSTEM IN PHARMACEUTICAL INDUSTRY: A REVIEW

Abstract

Inspection is a key to auditing. First, we want to check visually, and every system focuses on safety and effective manner. Each system fixes the quality of the drug product mainly self-inspection should be conducted before auditing, step by step, the process must inspect from starting material to the finished, approved product. Labels, equipments, materials to be checked as per GMP guidelines. The Principles of quality management system was demonstrated by good manufacturing practices. The inspector follows the guidelines accurately in the system; we want to check the personnel, hygiene, quality, scale-up activity and overall quality functions. In production system guidelines demonstrate the critical manufacturing test area check properly by the inspector in the field weighing, sieving, are performed in the system IPQC and FPQC conducted test to be check properly it follow as per GMP guidelines. In the facility and equipment system not, only equipment also inspects manufacturing, processing and production activity. In the laboratory and control system, check the stability test area and quality control area. The material systems order to monitor the component status accurately. In the packaging and labeling system, check the labels, storage control and mix-up area study properly. Finally, the regulatory inspector submits the report to PIC/S. This article focuses on six system auditing models and the guidelines for regulatory inspectors.