Developing a Practical Audit System for a Pharmaceutical Industry Based on Six System Inspection Model

Six System Inspection Model is used for auditing the Pharmaceutical Organization by the United States Food & Drug Administration (USFDA). Previously comprehensive quality management system was used which consisted of 20 points which was further modified as Six System Inspection Model for more convenience. The United States Food & Drug Administration (USFDA) uses the Code of Federal Regulation (21 CFR parts 210 and 211) for auditing. The objective of this topic was to use this model for six guidelines, i.e., 21 CFR parts 210 and 211, Schedule M (Scheme M-India), World Health Organisation (WHO), Medicines & Healthcare Products Regulatory Agency [MHRA (UK)], Therapeutic Goods Administration [TGA (Australia)], and Medicines Control Council [MCC (South Africa)] and to make consolidated information from these guidelines to make it readable and convenient for any moderate scale Pharmaceutical Industry to pass the audit by using single model, which consists of above six guidelines. The chapter consists of a checklist developed from consolidated information, arranged into Six System Inspection Model, comparison between comprehensive quality management system and Six System Inspection Model, and development of the seventh system. Overall, the authors suggest that if this audit system is followed by any small or medium scale Pharmaceutical Industry, it can prepare for the audit and use of the seventh system can help in covering extra points in the audit.