Module 3 Presentations

14/05/2024

Where to Test?  In the non-CQA world all steps could be tested since the important ones may not be known  Need to balance ‘perceived increased quality from testing’ against cost of: o Plant and laboratory resources o Increased cost of goods (API and product)  By concentrating on CQAs and hence Critical Steps resources are focussed on those aspects known (or suspected) to have the biggest potential impact on safety and efficacy

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What to Test  Range of tests and acceptance criteria must be justified  Typical tests could include o End of reaction (disappearance of reactants, appearance of product, purity of product) o pH, water by KF  End of reaction could be off-line HPLC with all the problems of method development  All tests should do something positive to improve control of the process and not be testing for testing’s sake (to try to look good!)

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