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GPhA Weighs In On API and QbD Issues Needing Clarification for Generics; OGD Outlines Starting Material Expectations

The designation of drug substance starting materials and the information that will need to be provided on them in Drug Master Files are among the issues on which members of the Generic Pharmaceutical Association (GPhA) are asking for further clarification from FDA’s generics office as it moves forward in upgrading its review processes with the support of quality-by-design (QbD) principles and user fee resourcing....

IPEC Announces Launch of EXCiPACT

The International Pharmaceuticals Excipients Council (IPEC) Federation announced in early February the launch of EXCiPACT – its new, voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients. Over 150 stakeholders representing developers, manufacturers, suppliers, distributors, and users of pharmaceutical excipients, […]

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....

Suppliers See Cost/Quality Disconnect in Big Pharma Decision Making

Suppliers are experiencing a significant disconnect between big pharma’s avowed quality-by-design-based supply chain objectives and the actual purchasing decisions it is making based only on price....

Relationships, Communication Gaps for Atypical Actives Aired at PDA/FDA Workshop

The relationships and the communication gaps between ingredient producers, distributors, dosage form manufacturers and regulators when atypical actives are involved received a public airing at a workshop cosponsored by PDA and FDA in March in Bethesda, Maryland....

Insights from Atypical Actives Workshop Could Drive Needed Technical/Regulatory Guidance, Participants Affirm

The insights that emerged at a PDA/FDA workshop on atypical active ingredients could form the basis for guidance that would clarify the regulatory expectations involved and help close the existing communication gaps in the manufacturing and distribution chain....

Excipient Master File System Advocated for EU

An excipient master file (EMF) system in the EU would facilitate the review process, spur excipient R&D and harmonize with other regulatory systems, advocates are saying....
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