Quality Systems

Kevin M. Kane, PhD, is CMC strategy director, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Eugene J. McNally, PhD, is vice-president, early engagement and regulatory strategy, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Jeff L. Garwin, PhD, MD, is associate clinical science director, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Debra A. Schaumberg is vice-president and global head, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Articles

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

An Intelligent Drug Development Paradigm

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

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Strategies for Contamination Control

Cliff Campbell is senior consultant at KPC.

Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”

Quality Quartets in Risk-Based Qualification

Editor of Pharmaceutical Technology Europe

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

Optimizing the Manufacture of Emerging Therapies

Quality quartets support an integrated and stable combination of
commissioning and qualification and quality risk management processes.

Points to Consider for Knowledge Management Acceleration

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

Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT

Joseph Mongillo, analytical research and development at Pfizer Inc., Groton, CT

Thomas Cullen, analytical research and development, AbbVie Inc., North Chicago, IL

Christian Metz works in Analytical Research and Development at AbbVie Inc., Ludwigshafen, Germany.

Katria Harasewych, quality, Merck & Co., Inc., Kenilworth, NJ

Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

Bringing Excipients into the Quality-by-Design Paradigm

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Quality by Design