Change Control and Its Role in Continuous Quality Improvement-4Challenges

In the pharma manufacturing, change alludes to any adjustments in materials, facilities, utilities, product design, formulations, processes, packing/labeling, equipment, computer systems, including all its related documents such as SOPs, STPs, etc.

A change control system is used to handle a relatively small/simple adjustment, such as a part replacement in an manufacturing equipment/analytical instruments in the laboratory or an version revision of existing document or creation of new documents,  otherwise it change control system can also be used to rectify/close an issue serious enough to shut down production.

The way that change is unavoidable makes control a basic factor, particularly in FDA and other regulatory conditions, where inappropriate or “uncontrolled” changes could affect the safety and efficacy of products and directly impact public health and safety.  Challenges during execution of Change Control Systems and their possible rectifications

Correspondence: Correspondence breakdown is perhaps the most well-known challenge, especially for organizations that rely on tribal knowledge or classical paper-based systems to manage change. Regardless of whether the breakdown displays as lack of timely follow up, objective delays in completion of work or completion of work in wrong or erroneous way thus comprehensively increasing the risk of cGLP and cGMP noncompliance. 

Updating of Documents: After Correspondence or communication gap in the organization, the second most important challenge regarding change control is documentation, such as timely and frequently updated old documents with new updated versions which is profoundly inclined to human error.

Total Time Required:  The total time required to initiate, follow-up, track and execute change control, should be minimum to make change effective. Hence online tracking system should be implemented to control Total turnaround time.

Training Challenges: When change happens, you are needed to prepare all representatives who will be influenced by the change. When proper training is isolated outside the change request framework, for what it's worth in a run of the mill paper-based framework, changes in SOPs, strategies, and different archives frequently become lost despite any effort to the contrary.

Thus defining what is change control, ways and tools to control and execute change control for small/minor or major changes is a must for every organization to increase customer satisfaction and prevent expensive and humiliating product recalls and cGLP, cGMP violations.

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