Joseph A. Albanese

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

Articles

Monograph Development: How to Participate; How to Harmonize

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

A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials

This case study is based on the experience of one of the authors but is applicable to all companies across the broader industry, illustrating the potentially surprising point that some compliance difficulties may be of the company’s own making.

Monograph Development: Why and When to Participate

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.

Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon

This final article in the series has two purposes: to summarize 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.

A Practical Approach to Pharmacopoeia Compliance

This article presents a case study at the intersection of monograph development and compliance.

Detailed Consideration of Global and National Pharmacopoeias

An understanding of global and national pharmacopoeias is crucial to understanding change processes and access to different markets.