Quality Systems

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

Greater collaboration and understanding are needed to ensure the correct grade of excipient is used in drug products.

Understanding the Value of Excipient Grade

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

USP Permits Use of Non-Animal-Derived Reagents for Endotoxin Testing

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

Compounding Overview: Primary Considerations for the Workplace

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA

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

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Complying with Compendial Requirements

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

In Equal Measures: The Importance of Excipient Quality

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

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.

Compendial Compliance