Alternate Sources for Excipients

Frequently, pharmaceutical manufacturers institute a system of dual sourcing of 'key' excipients as part of a contingency strategy. Functional equivalence of excipients from different suppliers/different sites of manufacture require careful evaluation and presumes that we understand which excipient characteristics are crucial for process and/or final product performance.

Functional equivalence is not like bioequivalence where there are well defined criteria that must be met to justify a claim of bioequivalence. In some applications we may find alternate source excipients that are truly equivalent in all aspects. However, in other applications, functional equivalence may mean answering the question "what changes to the unit process(es) are needed to produce a bioequivalent product using this alternate source excipient?"

FinnBrit Consulting has all the necessary knowledge and experience to advise on all functional equivalence issues relating to excipients.

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