It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

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

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Digitalization of QbD Risk Assessments

Topic

Articles

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate. 

Precautionary Measures Recommended in Use of Valproate Medicines

Ashley Boam, MSBE, is the Director of the Office of Policy for Pharmaceutical Quality in FDA’s Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research. 

Theresa Mullin, PhD serves as CDER’s Associate Director for Strategic Initiatives and leads CDER’s International Program in FDA.

Harmonization of global regulations fosters innovation and ensures quality medicines.

The Global Regulatory Village

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Artificial Intelligence in Pharmaceutical Manufacturing

Barbara Scott is a Master Reviewer at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients, Barbara.Scott@fda.hhs.gov.

David Green is a Senior Pharmaceutical Quality Assessor at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

Marlene Kim is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff.

Naomi Kruhlak is Scientific Lead, Computational Toxicology Consultation Service at FDA Center for Drug Evaluation and Research/Office of Translational Sciences/Office of Clinical Pharmacology/ Division of Applied Regulatory Science.

Tyler Peryea is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff.

David Skanchy was the Division Director (retired) at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Master File Submission of Structures

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

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

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

MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.

PharmaKure Gets Nod from MHRA to Trial Drug Targeting Amyloid Deposits

The potential for superpotent drug initiated the voluntary recall.

Leiters Health Recalls Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments