Pharmaceutical Change Control Process

A resident of Mount Laurel, NJ, Kaushal Prajapati is a pharmaceutical manager with experience overseeing key product development and validation processes. A manager with Hikma Pharmaceuticals, Kaushal Prajapati is experienced in change control.

Change control consists of a set of controlled processes and actions required to ensure a change doesn’t negatively affect a product’s quality, safety, efficacy or compliance. A control can either be proactive, which is a planned change, or reactive, in order to deal with the results caused by an unplanned change. The entire change control process should be clearly defined, communicated, and formalized in an organization’s quality manual.

A change control plan should identify actions, control limits, inputs, and outputs that are required to successfully implement the anticipated change. The process should also ensure that an organization’s equipment, facilities, processes and systems remain compliant after the change has been effected. Appropriate staff training and inclusion of any new or updated GMP (good manufacturing practice) documentation is also a key part of the process. Finally, change control should ensure all products in a changed state have acquired the necessary regulatory approvals before they are released into the market.