Quality Systems

Articles

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective. 

Ensuring API Quality—A Pharmacopeia Perspective

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Steven J. Lynn is executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Verifying Compendial Methods

Jennifer Markarian is a contributing editor for 

 USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

Facilitating Biopharma Continuous Manufacturing

USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.

USP Developing mRNA Quality Guidelines to Help Bring Innovative Medicines to Market Faster

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 director, 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.

Compendial Compliance