CHANGE CONTROL

Description

Change control in the pharmaceutical industry is a systematic process of managing and documenting changes to a product, process, or system. It is a critical part of quality management in the pharmaceutical industry, as it helps to ensure that changes are introduced in a controlled manner and that the impact of those changes is fully understood.   

Change control is necessary because changes can have a significant impact on the quality, safety, and efficacy of pharmaceutical products. For example, a change to a manufacturing process could lead to product contamination, while a change to a product formulation could reduce its effectiveness. By following a change control process, pharmaceutical companies can minimize the risk of introducing changes that could have negative consequences.

1. Initiation: A change request is submitted, detailing the proposed change and its justification.  
2. Evaluation: The change request is reviewed to assess its potential impact on product quality, safety, and efficacy.   
3. Approval: The change request is approved or rejected by the appropriate authority.  
4. Implementation: The change is implemented according to the approved change control plan.  
5. Verification: The change is verified to ensure that it has been implemented correctly.
6. Closure: The change control process is closed once the change has been successfully implemented and verified.