BioPharm International-12-15-2019

Pharmacopoeia Compliance Series

December 15, 2019

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

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

Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.

Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.

Regulatory Resources

December 15, 2019

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

Regulatory Resources

December 15, 2019

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

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products