Deviation And Change Control In Pharmaceutical Manufacturing

By David Butcher, Staff Writer, MasterControl

In pharmaceutical manufacturing, it is vital to strictly comply with established policies and procedures to maintain control over operations. Uncontrolled changes, such as deviations, can compromise both the safety and quality of products, as well as their regulatory status, which has direct implications for public health and safety. This underscores the importance of effective change control. Explore the differences between change control and deviation as well as deviation management in the pharmaceutical industry, change control processes in the industry, elements of Corrective and Preventive Action (CAPA), and how to best approach the interconnected processes of deviation, change control, and CAPA.