CCR
Excellence in Change Management | Industry Best Practices for QMS
Change Management is a critical process within a Quality Management System (QMS) that ensures all modifications are systematically evaluated, implemented, and verified to maintain compliance, quality, and efficiency. Following are the critical stages or steps as a part of the Change Management process are: Raise a Change Request Cross Functional ... Read More
Types of Change Control in Pharmaceutical Industry
In pharma industry, any proposal for change requires evaluation of the change against the marketing authorization (MA) for the product, Good Manufacturing Practice (GMP) guidelines, and patient safety. Most importantly, consideration must be given to the impact of the change on the patient safety. This is the primary concern when ... Read More
Change Control in Pharmaceutical Industry
Change Control is an important process within a Pharmaceutical Quality System. It involves providing justification for changes. A Pharmaceutical Quality System should enable continual improvement and facilitate change. It should include arrangements for the prospective evaluation of planned changes and approval prior to implementation. There should be checks that the ... Read More