Joseph A. Albanese is the director of Analytical Strategy and Compliance at Janssen Research and Development, LLC.

Joseph A. Albanese

Articles

Processes, people, and tools are necessary to comply with the pharmacopoeia and approved drug product registrations.

Pharmacopoeia Compliance: A Practical Guide

This article details the more operational aspects of monograph submissions, answering the question of how to participate.

Monograph Development: How to Participate; How to Harmonize

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. 

A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials

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. 

Author | Joseph A. Albanese