Acceptability of Standards from Alternative Compendia

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Do your standards require compliance with multiple compendia? You may be able to simplify your standards testing.

The latest addition of the MAPP (Manual of Policies and Procedures) 5310.7 – Acceptability of Standards from Alternative Compendia (BP/EP/JP) published in January 2017 states that it is reasonable to accept an applicant’s proposal to use a quality standard from the BP, EP, or JP as part of the specifications for an excipient, drug substance, or drug product in the drug application, if the standard in the BP, EP, or JP is equivalent to or better than the corresponding standard in the USP/NF.

This is useful information for those responsible for marketing authorization or incoming goods control in the pharmaceutical industry.

Download the document here.