An interesting article was published by Regulatory Focus, a RAPS Publication [link], about the FDA issuing a warning letter to Cipla. The first finding in the warning letter [link] discusses inadequacies in quality defect complaint investigations. This investigation linked product issues to defective supplier parts. However, the pattern of increased complaints persisted even with batches produced after the identified defective part lots.

There was a particular paragraph in the warning letter that caught my eye as a process validation practitioner.

“Inadequate container-closure parts or assembly processes can directly lead to production of poor-quality inhaler medicines with severe functionality or integrity defects, including but not limited to failure to dispense, inadequate dosing, or leaking units. It is essential that your manufacturing processes remain in a continued state of control to ensure that your rescue inhaler products reproducibly deliver the required dose for consumers who rely on your medicines.”

The mention of “assembly processes” as another possible source of poor-quality products highlights a key area that process validation directly addresses. The Form 483 report [link] mentions a filling line in the process, indicating the use of equipment, not just manual assembly. The FDA’s expectation of a “continued state of control” can also be called a validated state.

It's crucial for drug and device manufacturers to understand that defects can arise not only from the product itself but also from the manufacturing processes. Adopting a proactive approach through process optimization and validation can save costs in the long run by reducing quality investigations and compliance risks, as demonstrated in this example. The FDA acknowledges that companies may lack in-house expertise and, in this case, strongly recommends engaging a consultant.

Don't let your company be the next FDA headline. Partner with experts in process validation to ensure compliance and quality. Act now for a future of certainty and success.