Process Development

Oct 02, 2017
Pharmaceutical Technology
Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.
Oct 02, 2017
Pharmaceutical Technology
Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.
Sep 20, 2017
Equipment and Processing Report
Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.
Sep 02, 2017
Pharmaceutical Technology
Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
Sep 01, 2017
Pharmaceutical Technology
Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Aug 02, 2017
Pharmaceutical Technology
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
Jul 02, 2017
Pharmaceutical Technology
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Jul 02, 2017
Pharmaceutical Technology
Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.
Apr 01, 2017
Pharmaceutical Technology
Process analytical technology, based on monitoring particle size distribution and tracking coating thickness measurements in real time, can be used to predict the dissolution of polymer-coated multiparticulates.
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