Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement for drug companies seeking to market products in that region. The multiple pharmacopoeias around the world are frequently revised and expanded, presenting challenges for bio/pharmaceutical companies that must monitor this activity.

This article examines the revision process of global and national pharmacopoeias, the publication schedules, and describes differences between the procedures of the various authorities.

This article is part of a series that will be published in 2019–2020. 

Pharmaceutical Technology’s December 2019 Regulatory Sourcebook

eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 17–25

When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Revision Process for Global/National Pharmacopoeias," 

Pharmaceutical Technology Regulatory Sourcebook eBook

Articles

Pharmacopoeia Compliance Series

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)

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

Regulatory Resources

Regulatory and Standard Setting Organizations

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

Resources, Guidelines, and Guidance Documents

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, as equipment evolves and use of process analytical technology increases.

	Design of experiments (DoE) is used by drug developers to gain deeper insights into their products and processes.

	By using statistical methods to perform multivariate analysis, the approach allows users to assess the impact of various factors on each other and on an outcome or may make these techniques easier to apply.

eBook: Regulatory Sourcebook, December 2019
	December 2019
	Pages: 14–16

	When referring to this article, please cite it as A. Shanley, “Moving from Compliance to Quality," 

Features

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.

Design of Experiments Gains Ground in Biopharma Development

While the number of warning letters issued by FDA has declined slightly, recurrent violations include poorly maintained equipment and facilities, insufficient cleaning validation, inadequate written procedures for quality testing, and inadequate controls over data and computer systems. Effective, ongoing monitoring programs-for regulatory agency enforcement actions and pharmacopoeia updates-are essential for bio/pharma compliance.

eBook: Regulatory Sourcebook, December 2019
	December 2019
	Pages: 4–5

	When referring to this article, please cite it as R. Peters, “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.

Warning Letters Signal Steps to Compliance

The purpose of a quality risk management plan is to help ensure continued compliance with regulatory requirements, such as good manufacturing practices or good laboratory practices, when events occur during manufacturing that potentially impact patient safety and product quality.

	Learn the four basic elements that should be included in a quality risk management plan.

eBook: Regulatory Sourcebook, December 2019
	December 2019
	Pages: 12–13

	When referring to this article, please cite it as S. Schneipp, “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


Quality Risk Management Plans Create Effective Quality Systems

Regulators and pharmaceutical manufacturers are debating the best way to measure quality. Discussions center on management and corporate cultures and how they impact operational excellence and customer-focused quality. Observers see the need for more proactive pharmaceutical company managers who actively support and invest in quality efforts and employee training.

eBook: Regulatory Sourcebook, December 2019
	December 2019
	Pages: 6–10

Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.

Moving from Compliance to Quality

To maintain ongoing compliance with current pharmacopoeia requirements, bio/pharmaceutical companies must be aware of periodic updates, determine the potential impact, and implement appropriate changes to their quality and regulatory documentation, processes, and procedures.

	This article details the surveillance activities carried out by industry to monitor pharmacopoeia revisions so that companies can establish effective, efficient, sustainable, scalable, and successful processes to address these compliance challenges.

	This article is part of a series that will be published in 2019–2020. 

eBook: Regulatory Sourcebook, December 2019
	December 2019
	Pages: 26–37

	When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions," 

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

Pharmaceutical Technology-12-15-2019