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Janssen Research and Development
Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC
October 02, 2022
Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
September 02, 2020
Processes, people, and tools are needed to comply with the pharmacopoeia and approved drug product registrations.
March 15, 2020
This article details the more operational aspects of monograph submissions, answering the question of how to participate.
The authors present a case study with raw materials and excipients, where a consistent, cross-functional approach is needed to ensure the appropriate selection, sourcing, testing, and filing of the materials used to manufacture bio/pharmaceutical products in a global environment, ensuring compliance with applicable compendial and regulatory requirements.
This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.
This article summarizes all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world. This look into what is on the horizon is important to help companies prepare for the inevitable changes and ensure the continued supply of quality medicines to patients globally.