CCR

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 managing change. Changes should drive…

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 quality objectives are achieved and…