Change Control from Initiation to Implementation in the Pharmaceutical Industry: A Comprehensive Review

Abstract

Change control plays a role in cGMP, just as all aspects of quality management should continually strive for enhancement. It works with a prior mechanism that empowers designated personnel across fields to assess, as well as having permission to authorize proposing or doing modifications that would impact the status that was prevalidated for the process system, including facilities, systems, and equipment. Change management involves overseeing changes in staff, protocols, operations, and product standards. These changes can occur in areas such as manufacturing, quality control, quality assurance, engineering, research and development (R&D), and marketing. Depending on their significance, changes may be categorized as critical, major, or minor; they may also be classified as emergency, planned, or unplanned based on their nature. Effective change management encompasses the coordination of personnel resources along with protocols to ensure consistency in operations and product excellence. It is a component of GMP compliance, as regulatory bodies mandate companies to demonstrate proficiency in managing changes. The process entails initiating a change request, followed by evaluating its impact on the product before devising an action plan for implementation, ultimately culminating with the Change Control Board (CCB) making decisions regarding the proposed changes.