Quality Systems

Articles

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

FDA Looks to Modernize Generic Drug Labels

New FDA guidance developed to identify lapses in data integrity and promote best practices.

FDA Answers Data Integrity Questions

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

FDA Hits Valsartan Manufacturer with Warning Letter

Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.

Integration of two separate chromatography data systems boosts workflow efficiency.

The Benefits of an Advanced Chromatography Data System

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

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

Investigation Timeliness vs. Thoroughness: Finding the Right Balance

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

Microbial identity data can be critical for determining contamination sources.

Microbial Identification Strategies for Bioburden Control

Agnes Shanley is senior editor of Pharmaceutical Technology.

Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.

Going Beyond the Surface to Ensure Supplier Quality

Kent Malmros is senior director of training at Veeva Systems. He has spent the majority of his career delivering technology-enabled training solutions to life-sciences companies and has held leadership positions at companies that include AdMed, ClearPoint (Red Nucleus), and UL EduNeering (UL).

Simplified role-based training can lead to better quality metrics and compliance.

Make Training a Strategic Asset: Five Key Steps

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.


Quality Assurance/Quality Control