Tag: USP

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Featured image for a GMP Insiders article on USP Pharmacopeial Forum 52(5), showing regulatory documents clipped together. The issue includes proposals on oral drug product leachables, glycol impurity testing, and revisions to compendial Identification requirements.

USP PF 52(5): New General Chapter ⟨1664.5⟩ on Oral Drug Product Leachables, Revised ⟨469⟩ Glycol Test, and General Notices Revisions

USP Pharmacopeial Forum 52(5) introduces proposals covering oral drug product leachables, glycol impurity testing in ethoxylated substances, and revisions to...
USP-NF PROPOSED DRAFTS IN PF 51(3)

USP–NF PF 51(3) Draft Published

USP–NF PF 51(3) draft introduces new PAT, content uniformity, parenteral leachables, and CBD standards, enhancing GMP control and regulatory alignment....
USP Introduces New Chapter for Early Adoption Non-Animal Derived Endotoxin Testing Methods

USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption

USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards....

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