Quality Systems

Sean Milmo is a freelance writer based in Essex, UK.

Articles

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

Playing the Waiting Game with GMP Guideline Revisions

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

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

Broadening Europe’s Research Horizons

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.

A Meeting of Minds

Lonza’s fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.

Robotic Solution Simplifies and Speeds Endotoxin Detection

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

New York Facility Receives Warning Letter

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

Singapore Facility Receives FDA Warning Letter

Agnes Shanley is senior editor of Pharmaceutical Technology.

FDA Commissioner Scott Gottlieb and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, expect shortages to ease within six months. Although recycled solvents and materials are a prime concern, questions remain about the sources of contamination.

FDA Releases List of 'Safe' Valsartan and ARBs While Experts Explore and Debate Root Causes of Contamination

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

Quartic.ai Introduces AI Platform for Process Manufacturing Operations at INTERPHEX 2019

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Dijana Hadziselimovic is a technical services laboratory specialist for the Life Sciences Division at STERIS.

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

Cleaning Chromatography Resin Residues from Surfaces

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

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Quality Assurance/Quality Control