Quality Systems

Articles

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Using Analytical Assays to Ensure Biosimilar Quality

Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo. 

Defining Drug Stability with Dissolution Testing

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 editor of 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.


Quality by Design