Quality Systems

Articles

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

Using Industry 4.0 to Optimize Oral Solid Dosage Form Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Tools help improve understanding of excipient risk in formulating OSD drugs.

Mitigating Risk in Formulating with Excipients

Agnes Shanley is senior editor of Pharmaceutical Technology.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset. 

Getting to the Root of Quality Problems

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.

Design of Experiments Gains Ground in Biopharma Development

Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.

Moving from Compliance to Quality

Sean Milmo is a freelance writer based in Essex, UK.

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.


The Challenges for Regulators in the Digital Age

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.


DOE Gains Ground in Biopharmaceutical Development

As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.


QbD Takes Shape for Topical Pharmaceuticals

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues. 

Generics: Getting Beyond “File First, Figure it Out Later”

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

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.

Fumiko Tamura is associate manager, GSK, CMC Regulatory Affairs, Tokyo, Japan

Hatsuki Asahara is department manager with GSK, CMC Regulatory Affairs, Tokyo, Japan

Adam Watkins is scientific leader, GSK, product development and supply, David Jack Research Centre, Ware, UK.

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies. 

Quality by Design