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Quality by design (QbD) in bio manufacturing Shruti Talashi
December 01, 2023
Quality by design is the standard approach used for demonstrating and achieving consistent, high quality product. Rather than relying on just the post production testing, QbD practice rather encourages to improve quality at every stage of the process.
Powder Flow:Developing a Design Space for OTC Manufacturing Tim Freeman
October 21, 2020
Tim Freeman, Managing Director at Freeman Technology, explains how comprehensive, process relevant characterization of wet granules can lead to control of tablet CQAs and assist Design Space definition in the manufacture of an OTC medicine.
Powder Flow: Tools for Powder Characterization Tim Freeman
August 15, 2018
The potential benefits of Quality by Design, the approach enshrined in ICH Q8 - Pharmaceutical Development, include greater flexibility with respect to regulation, enhanced process efficiency and better product understanding.
Powder Flow: Getting to Grips with Quality by Design Tim Freeman
May 18, 2018
Quality by Design (QbD) involves switching from an empirical approach to one based on knowledge, understanding and sound science.
Siemens and Perceptive Engineering combining software solutions for the pharmaceutical industry europeanpharmaceuticalreview
February 28, 2018
Siemens AG and Perceptive Engineering Ltd announce a partnership which offers Perceptive’s PharmaMV and Siemens Simatic Sipat software products closely integrated to provide a versatile solution for advanced control...
Tim Freeman's Powder Flow Feature: Embracing QbD and PAT Tim Freeman
January 15, 2018
In recent decades, the pharmaceutical industry has employed innovative, cutting edge technology to undertake research, and to develop new drugs which deliver immense value to society.
Quality by Design -- Experimental strategies for implementing Quality by Design Ronald D. Snee, PhD
April 25, 2017
Much has been learned about the use of Quality by Design (QbD) since it was proposed by the FDA and ICH (2005) some five years ago. While the benefits of the approach are generally acknowledged, its implementation has been slower than expected.
Sartorius Supports Mainstream Adoption of QbD contractpharma
January 25, 2017
Develops technology platform to meet the requirements of today’s upstream bioprocessing