Quality Systems

Articles

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.

Final Product Inspection: Making the Most of Your Processes

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study  is following ISO or USP standards. 

Discussing E&L Study Design Between ISO and USP (AAPS PharmSci 360) 

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

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

Videos

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Making Visual Inspection Accessible with Luo Automation at CPHI Barcelona

H. Gregg Claycamp, MS, PhD, is a Risk and Decision Analysis Consultant, hgclaycamp@gmail.com.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making. 

Quality Assurance/Quality Control