Revision Process for Global/National Pharmacopoeias (eBook)
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 (eBook)
An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.
Warning Letters Signal Steps to Compliance
Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.
Lessons from FDA 483s and cGMP Inspection Data
Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.
Resources, Guidelines, and Guidance Documents
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Regulatory and Standard Setting Organizations
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Quality Risk Management Plans Create Effective Quality Systems
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products
