Compendial Compliance

A Practical Approach to Pharmacopoeia Compliance (eBook)

March 15, 2020

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

Bovine Heparin Meets Acceptable Impurity Levels

February 17, 2020

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

The Search for Transparency in Excipient Sourcing

February 02, 2020

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.

Revision Process for Global/National Pharmacopoeias

December 15, 2019

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 (eBook)

December 15, 2019

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

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions

December 15, 2019

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

Detailed Consideration of Global and National Pharmacopoeias

December 15, 2019

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

Industry Pharmacopoeia Surveillance Process in Detail

December 15, 2019

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

Regulatory and Standard Setting Organizations

December 15, 2019

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

Resources, Guidelines, and Guidance Documents

December 15, 2019

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.