Module 3 2019

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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