Quality Systems

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Articles

Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.

European Pharmacopoeia Updates: EDQM Tackles Nitrosamine Impurities

Jaap Venema, PhD, is Executive Vice President and Chief Science at US Pharmacopeia (USP).

Jennifer Devine, JD, is Senior Vice President, Documentary Standards and Compendial Policy at US Pharmacopeia (USP).

Public health challenges have highlighted the need for agility in maintaining the quality of medicines. 

Public Trust in Medicine Quality as Public Health Challenges Emerge

Resources, Guidelines, and Guidance Documents Directory 

Jennifer Putnam is AR&D supervisor II, Perrigo

Katherine L. Ullman is president, KLU Consulting, LLC

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

George Collins is vice president, Vanderbilt Chemicals LLC. 

Douglas G. Muse is consultant—Compendial Affairs, Eli Lilly & Co.

Brian Carlin is director QbD/Regulatory, DFE Pharma US

Joseph Zeleznik is technical product manager, IMCD US

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.


Understanding Concomitant Components in Pharmaceutical Excipients

USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.

USP, COVID-19, and Plans for the Future

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

EDQM Combats COVID-19 and Makes Plans for Future

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories  in the European Union OCABR Network. 

EDQM Publishes Guidelines on Batch Release for COVID-19 Vaccines

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

Resources, Guidelines, and Guidance Documents

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Processes, people, and tools are needed to comply with the pharmacopoeia and approved drug product registrations.

Pharmacopoeia Compliance:  A Practical Guide

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

Compendial Compliance