Quality Systems

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

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

Articles

This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.

A Practical Approach to Pharmacopoeia Compliance (eBook)

Sean Milmo is a freelance writer based in Essex, UK.

EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.


Playing Catch Up with Big Data in Europe

Propess (dinoprostone) from Ferring Pharmaceuticals has achieved approval from the Minister of Health, Labour, and Welfare (MHLW) in Japan, making it the first pharmacological treatment for cervical ripening to be approved in the country for more than 20 years.

Pharmacological Treatment for Cervical Ripening Gains Approval in Japan

The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity. 

Novartis Announces EC Approval of MS Drug

The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.

Revision Process for Global/National Pharmacopoeias

This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.

Revision Process for Global/National Pharmacopoeias (eBook)

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions

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

Detailed Consideration of Global and National Pharmacopoeias

The process used to monitor and participate in pharmacopoeial changes is described.

Industry Pharmacopoeia Surveillance Process in Detail

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory/GMP Compliance, Emerging Markets