Importance of Change control in Pharmaceutical Industry: A Review

Abstract

Change Control is the process that management uses to identify, document and authorize changes to an IT environment. It minimizes the likelihood of disruptions, unauthorized alterations and errors. The change control procedures should be designed with the size and complexity of the environment in mind. Change control is used to ensure changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. Change control is used in various industries, including in IT, software development, the pharmaceutical industry, the medical device industry, and other engineering/manufacturing industries. For the IT and software industries, change control is a major aspect of the broader discipline of change management. There are two types of changes 1. Disruptive change 2. Dynamic change. is a non-localized future irreversible and change that affects a portion of an industry. This can be caused by changes in market trends causing a shift in the mode of production to fit the customer demands. Dynamic Change is multi-dimensional change that is predictable on a measurable scale. Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. Manufacturing changes (i.e changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.