In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
For the bio/pharmaceutical industry, compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the ...
The new <1226>, 'Verification of Compendial methods' was published in second supplement to USP 30 - NF 25 (2007) and is now official. Compliance to USP <1226> is one of the FDA requirements for ...
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