Quality Systems

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Articles

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Sanjay Sharma is vice-president and head of technology transfer at Lupin Pharmaceuticals

Amol Galande is senior manager of the process development laboratory at Lupin Pharmaceuticals

Marzena Ingram is senior manager, quality and compliance at Eurofins CDMO. She led and hosted several cGMP audits, and has diverse quality assurance and technical operations experience. 

Robert Rhoades is managing partner at Validant.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

Assessing Legacy Drug Quality 

Shahid Manzur is principal, Consulting, EY, shahid.manzur@ey.com

Automated systems help detect and resolve quality issues.

Best Practices for Pharma Manufacturing Quality Teams

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

Applying a QbD approach helps address excipient variability and other quality features.

QbD Helps Evaluate Excipient Variability 

Editor of Pharmaceutical Technology Europe

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

Focusing on Accelerated Formulation Strategies

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.

Timothy Schofield is owner and consultant, CMC Sciences, LLC;

David Lansky, PhD, is president, Precision Bioassay, Inc.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality. 

Reducing Uncertainty of an Analytical Method through Efficient Use of Replication

Jennifer Markarian is manufacturing editor of BioPharm International.

Integrated, paperless data systems can improve efficiency and quality.

Digital Tools Enhance Raw Material Traceability

Garima Thakur is a graduate student in the Department of Chemical Engineering at the Indian Institute of Technology New Delhi.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of BioPharm International's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

FDA: Stick with Approved EUAs for COVID-19 Vaccines

The collaboration addresses the need for risk mitigation plans in cell therapies.

Quality by Design