My master's thesis is about retesting periods in the pharmaceutical industry. The company I'm with has asked me to find a way to reduce the costs of raw material retesting (by doing less tests, less frequently), and extrapolate data, so that, every time they buy said material from the same provider (assuming the formulation hasn't changed) it can be inferred that the product will have the same retesting date and further testing is unnecessary. My top question right now is: When a company buys raw material for drug manufacturing, is the supplier obliged to provide the stability studies for said material to the buyer?
Materials have grades in terms of their purity, stability or requirement of other precautions. Thus, the supplier should be responsible for matters other than the specifications of that particular material.
Thanks Alemu! Follow up question, if you'd please. If an API is retested, can it be given another retest date, based on the manufacturer's studies and the new ones? Can it be retested indefinitely if it meets the necessary requirements?
Thanks
Each manufacturer should test the stability of the API they manufacture and provide this information to the buyer. Each API has two time "limits", one is the retest period the second is expiry period. Once manufactured, the material should be periodically retested as per the retest period (say once in two years). Once the expiry is reached, it can be used no longer. Typical expiry is 60 month from the date of manufacture for "stable" substances, but can be as short as two years or shorter for labile products, such as low molecular weight heparins or beta lactam antibiotics.
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