Quality Systems

Claude Price is the head of Clinical Data Management at Quanticate.

Articles

Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.

The Importance of Quality Data for Regulatory Submissions

Amin Ziaie, QRM Merck & Co., Inc, PRST, the Technological University Dublin.

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

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

This article explores the emergence of subjectivity in ICH Q9 (R1).

Shining a Light on the Long Shadow of Subjectivity in Quality Risk Management

Feliza Mirasol is the science editor for 

Videos

This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.

Drug Digest: The Rush for Quality Data and the Means to Protect It

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.

Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release

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

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

Podcasts

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

Drug Solutions Podcast: The Biosimilars Landscape

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Cliff Campbell is senior consultant at KPC.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

Quality Quartets in Risk-Based Qualification: 

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.

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

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. 

Quality Assurance/Quality Control