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USP and IPEC-Europe Weigh in on GDPs for Excipients

USP and the European branch of the International Pharmaceutical Excipients Council (IPEC-Europe) have both released guidance for pharmaceutical companies on the evaluation and handling of excipient distribution....

USP Publishes First Medicines Compendium Standards

In late November, USP published the first ten standards to be included in its Medicines Compendium (MC).  The new standards cover medicines used as anti-HIV agents, antivirals, analgesics, oral contraceptives and antiparasitic treatments. The recently authorized standards cover: acyclovir, acyclovir topical cream, amlexanox, chloroquine oral solution, chloroquine phosphate, chloroquine sulfate, etoricoxib, nelfinavir mesylate, ormeloxifene hydrochloride […]

PDG Advances International Pharmacopeial Harmonization Effort

In mid-November, the European Directorate for the Quality of Medicines (EDQM) reported that the Pharmacopeial Discussion Group (PDG) has completed harmonization of 28 of the 35 General Chapters and 41 of the 61 excipient monographs in its current work program. Formed in conjunction with ICH, the members of the PDG are the European Pharmacopoeia (EP), […]

China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....

USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage

The particulate and reactivity issues that have been surfacing involving drugs and biologics in glass containers and the increased interest in polymer alternatives are prompting USP to revise and expand its related compendial standards and guidance....
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