Quality Systems

Rick L. Friedman, MS, is Deputy Director for Manufacturing Quality, FDA Center for Drug Evaluation & Research.

David Lebo, PhD is Professor of Pharmaceutics, Temple University School of Pharmacy.

Lawrence Liberti, PhD, BPharm, RAC, is Director, The University of Southern California (USC) DK Kim International Center for Regulatory Science

GK Raju, PhD is Light Pharma CEO, and Research Affiliate, Massachusetts Institute of Technology.

Articles

This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.

ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable Facilities

Martin J. Lipa, PhD, martin.lipa@prst.ie, is a senior research fellow at Pharmaceutical Regulatory Science Team.

Anne Greene, PhD, is director PRST, Technological University Dublin.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Knowledge as the Currency of Managing Risk

Kelley Waldron, PhD, is business unit manager, Quality and Manufacturing Science Consulting, at ValSource.

Tiffany Baker, MBA, is senior consultant at ValSource.

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach. 

Developing an Optimized Risk Assessment Portfolio—The Quality Risk Management Master Plan

Analytical methods and tools play a pivotal role in cleaning validation.

Proving It’s Clean with Analytics

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

Consent Decree Entered Against Pharmasol

Feliza Mirasol is the science editor for 

Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.

Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

The bio/pharmaceutical industry is struggling with the challenge of staffing and training.

Training for Operational Excellence

Kari Miller is senior director, Product Management, QMS, IQVIA.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

Revitalizing Quality Management Processes through Digitalization

Kate Coleman is Principal Quality and Compliance Consultant with Arriello Ireland.

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

The ICH Q9 Revision and a Renewed Focus on Quality Risk Management Fundamentals 

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

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Quality Assurance/Quality Control