When a parameter is classified as a Critical Quality Attribute (CQA), there can be a natural tendency to conclude that it should also become a release specification. After all, if it is critical, shouldn’t it be tested and controlled at batch release?
In practice, the answer is often more complex.
A well-designed control strategy considers the entire manufacturing process, not just the final specification. Some attributes may be more effectively controlled through raw material controls, process parameters, in-process testing, or process validation than through routine release testing.
The challenge is therefore not to justify why a parameter is important. The challenge is to demonstrate that it is adequately controlled. The strongest regulatory submissions are often not those with the most specifications, but those with the most convincing explanation of why each control was selected.
Many regulatory questions arise not because authorities disagree with a company’s control strategy, but because the scientific rationale behind that strategy has not been clearly articulated.
Have you encountered regulatory questions where the discussion was less about the control itself and more about the rationale behind it?
Interested to learn more about our experience with control strategies? Reach out to us via info@starodub.nl.
