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

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Articles

Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Lynparza Approved in Great Britain

Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.

FDA Approves Novel ASMD Treatment from Sanofi

The patent applications are for programs concerning lupus, idiopathic pulmonary fibrosis, and chronic kidney disease.

Aria Pharmaceuticals Files Applications for Six Provisional Patents

Alasdair Leckie is operations director at Rephine Ltd, a firm of deeply experienced GMP auditors which proactively help pharmaceutical companies around the world with their supply-chain quality assurance. Alasdair has been with Rephine for nine years and has a Bachelor’s Degree in Chinese and Economics from SOAS University of London.

A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients. 

Will Remote Pharma GMP Auditing Endure Post-Pandemic?

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) 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

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Creating building blocks for good manufacturing practices is essential.

Building GMPs for Solid Dosage

Moritz Perscheid is a pharmaceutical chemist at LGC.

It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.

The Value of Primary Working  Standards in Pharmaceutical Quality Control

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.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments