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.
Regulatory and Standard Setting Organizations
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Resources, Guidelines, and Guidance Documents
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Design of Experiments Gains Ground in Biopharma Development
Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.
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.
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
Moving from Compliance to Quality
Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.
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.
