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

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Congress Probes PBM Link to Higher Drug Prices

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% 

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety. 

Harnessing Technology to Ensure Drug Safety

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 discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms

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

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Excipients Impact Stability in mRNA-LNP Formulations

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Amanda Guiraldelli Mahr is scientific affairs manager, US Pharmacopeia.

Joachim Ermer is head of Analytical Lifecycle Management Chemistry Frankfurt at Sanofi.

Stephanie Sproule is a member. of the USP M&DQ EC.

Jean-Marc Roussel is a  member of the USP M&DQ EC.

Jaime Marach is member of USP Analytical Procedure Life Cycle Joint Subcommittee.

Horacio Pappa is senior director, US Pharmacopeia.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>

Suzanne Shelley is contibuting editor to 

Stockpiling excess inventory is no longer enough to respond to supply chain volatility. 

Taking Steps Toward Supply Chain Continuity

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Vaccine Development Builds on COVID-19 Breakthroughs

Cheryl Barton is director of PharmaVision, 

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments