Quality Systems

Manuela Gottschall is Head of Risk and Project Management, Global Quality at Roche.

Marie Schommer is Quality Manager at Roche Diagnostics GmbH.

Federico Colombari is Quality Risk Management Specialist at Roche.

Articles

A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Industry 1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual Verification 

Pietro Forgione is the vice-president of strategy at IDBS.

Innovation is driven through a strong digital backbone.

Accelerating Time-to-Insight Throughout the BioPharma Lifecycle

Scott Weiss is vice-president of Business Development and Open Innovation at IDBS.

An integrated approach to the data lifecycle is key to successful digital transformation.

Integrated Approaches to the Data Lifecycle

Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT

Joseph Mongillo, analytical research and development at Pfizer Inc., Groton, CT

Thomas Cullen, analytical research and development, AbbVie Inc., North Chicago, IL

Christian Metz works in Analytical Research and Development at AbbVie Inc., Ludwigshafen, Germany.

Katria Harasewych, quality, Merck & Co., Inc., Kenilworth, NJ

Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

FDA Authorizes Bivalent COVID-19 Boosters

Marie-Claire Beckers is global subject matter expert for QC Materials and Samples Management at GSK Vaccines.

Delphine Collete is global subject matter expert for QC Materials Management at GSK Vaccines.

Julie Barthuet is head Regulatory CMC&D Vaccines at Sanofi Vaccines.

Thierry Gastineau is Global Head of Quality Advocacy, Culture, & Innovation at Sanofi Vaccines.

Change of lot or extension of reference standard shelf-life is considered low
risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

Industry 1VQ Solutions: Change of Lot or  Extension of Shelf-life of Reference Standard

Amy Williams is director at Iperion—a Deloitte business.

EMA has announced a change of plan for the IDMP.

A Change of Tack for IDMP

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

New Legislation Overhauls Medicare Drug Pricing and Benefits

Cheryl Barton is director of PharmaVision, 

A new unitary patent system is due to come into effect in Europe later on this year.

What Impact Will the New Unitary Patent System Have in Europe

A Post Approval Change (PAC) in size of thermal shipping solution used for transport of product is considered a low risk provided it has been qualified and temperature monitored, and therefore can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Regulatory Oversight and Compliance