Quality Systems

Articles

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. 

A New Method for Risk Assessment of Pharmaceutical Excipients

Regis Cazes is strategic marketing director at Medelpharm, France, a company creating the STYL’One family of tableting instruments and providing contract lab services in powder characterization and tableting; rcazes@medelpharm.com.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

A QbD Approach to Shorten Tablet Development Time

Agnes Shanley is senior editor of Pharmaceutical Technology.

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

QbD and API Process Development: A Marriage of Chemistry and Engineering

Ke Wang, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Fangfang Liu, PhD, is manager of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Fasheng Li, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Aili Cheng, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Brad Evans, PhD, is associate director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Jingnan Zhang, PhD, is manager of Pfizer’s department of pharmaceutical science and manufacturing statistics.

A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation. 

Removing Subjectivity from the Assessment of Critical Process Parameters and Their Impact

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Evaluating Surface Cleanliness Using a Risk-Based Approach

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.

Critical Parameters in Transdermal Patch Manufacturing

Ian Elliot is senior director, global supply chain reliability, at Janssen Pharmaceuticals, Inc.

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

Reliability Rooms and the Move to Proactive Supply Chain Management

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

The Technological Evolution Driving Pharma’s Future

Frances DeGrazio is Vice President, Marketing and Strategic Business Development at West Pharmaceutical Services, Inc.

When it comes to getting the best out of quality by design, timing is everything.

A QbD-Based Approach to Drug Packaging and Delivery

Graham A. McGibbon is director of Strategic Partnerships at ACD/Labs, media@acdlabs.com

Sanjivanjit K. Bhal is director of Marketing and Communications, all at ACD/Labs, media@acdlabs.com

Andrew Anderson is vice-president of Innovation and Informatics Strategy at ACD/Labs, media@acdlabs.com

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

Quality by Design