Quality Systems

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.

Tech Transfer: Tearing Down the Wall

Melissa Hanna-Brown is external technology & collaborations lead at Pfizer.

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

Stephanie Katzenbach is senior scientist, New Biological Entities, Analytical R&D at AbbVie.

Andy Rignall is product technical director at AstraZeneca.

Annick Gervais is director, Analytical Sciences Biologicals at UCB.

JÃ¶rg Hoffmann is director, CMC Regulatory Compliance at Merck KGaA.

Jette Wypych is director, Attribute Sciences at Amgen.

Kieran McLaughlin is principal scientist at MSD.

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.

Oliver Grosche is director, Collaborative Solutions at Elanco.

Peter Hamilton is scientific leader at GSK.

Thomas Uhlich is laboratory head Analytical Development at Bayer.

Christof Finkler is Analytics Biochemistry site head at Roche.

Katrin Liebelt is analytical project leader at Novartis.

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.


Analytical Procedure Lifecycle Management: Current Status and Opportunities

A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.

High-Throughput Microplate Reader Cuts Down Screening Time

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

NIBRT, Valitacell Aim to Validate New Analytical Technology

FDA has issued a warning letter to Mylan citing GMP violations of finished pharmaceutical products manufactured at the company’s Morgantown, WV, facility.

FDA Issues Warning Letter to Mylan for Pharma Manufacturing Facility

The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.

StemGenex Biologic Laboratories Gets FDA Warning

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

FDA Modernizes Inspection of Sterile Products

Daniel Erickson is Product Strategy Manager at ProcessPro.

An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.

Enterprise Resource Planning Systems Provide Supply Chain Traceability

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL. 

User Requirements Specifications–How Difficult Can It Be?

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 paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Quality Assurance/Quality Control