It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Digitalization of QbD Risk Assessments

Topic

Articles

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

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

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel. 

Best Practices for Developing a Third-Party Auditing SOP

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.

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.

Industry 1VQ Solutions:  Change in Size of Thermal Shipping Solution Used for Transport of Product 

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality. 

Industry Perspectives on Quality–A Conversation with Pfizer CentreOne

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments