Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries

The Food and Drug Administration (FDA) or Drug Control Authority (DCA) in every country regulates the quality of pharmaceutical/medical devices/veterinary medicine. The main regulatory standard for ensuring pharmaceutical quality is Current Good Manufacturing Practice (cGMP) regulations for human pharmaceutical (veterinary pharmaceutical) all over the world. India and China command 40% of the world generic market share for pharmaceuticals, and the primary license granted in India by the state FDA is under Form 25 and Form 27 as per the Drug and Cosmetics Act, 1940 and the rules therein under. Auditing is an absolute necessity for a pharmaceutical company as it helps to review and evaluate the quality system of the organization. Remote auditing is one of the audit methods described in ISO 19011:2018 Annexure A1. It allows the auditor to communicate with people globally, accessing a wide range of information and data. It is a valid way of doing things for many reasons, such as saving money and hassle, cutting down on travel, and allowing audits to be run efficiently. However, there are some barriers, such as maintenance data security, time zone difference, poor Wi-Fi connections, and the lack of a personal touch. New information and communication technologies (ICTs) have made remote auditing more feasible, allowing for the inclusion of expertise in an audit that otherwise might not be possible due to financial or logistical constraints. However, there are limitations and risks posed by ICT in the fulfillment of audit objectives, such as information security, data protection and confidentiality issues, veracity and quality of the objective evidence collected, and environmental impact. The use of ICT for remote auditing will only be successful if the right conditions are in place.