Quality Systems

Amanda Guiraldelli is Scientific Affairs Manager, United States Pharmacopeia, Rockville, MD.

Articles

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017. 

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives. 

Evolution of Analytical Procedure Validation Concepts: Part I – Analytical Procedure Life Cycle and Compendial Approaches

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

USP Revises Drug Compounding Chapters

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

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

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

Biologic Standards in the Pharmacopoeias: An Update

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

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 manufacturing editor of BioPharm International.

 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. 

Compendial Compliance