Quality Systems

Emma Ramnarine, PhD, is Executive Director, Product Management & Development Operations, US Biopharma Operations at Boehringer Ingelheim Fremont, Inc.

Articles

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

Control Strategy: A Feedback-Feedforward ‘Controls Hub’ for Risk, Knowledge, and Product Lifecycle Management

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

FDA Releases Guidance on Using Remote Oversight Tools for Drug Approval

Videos

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future. 

Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Barriers to the Development of Continuous Manufacturing and ICH Q13 (PDA/FDA Joint Regulatory Conference 2023)

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

Rentschler Biopharma ATMP Facility Receives MHRA Approval

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

The Future is the Present: Artificial Intelligence in Pharmaceutical Manufacturing

Martin J. Lipa, PhD, martin.lipa@prst.ie, is a senior research fellow at Pharmaceutical Regulatory Science Team.

Anne Greene, PhD, is a professor at Technological University Dublin and director at Pharmaceutical Regulatory Science Team.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Knowledge as the Currency of Managing Risk: A Smart Investment for Patients

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

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

Clearing Up Confusion in Inspection Terminology

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.  

Regulatory/GMP Compliance