08. February 2016
Thursday, March 10, 2016 QbD (Quality by Design) is of growing importance to the pharmaceutical industry – both for novel drugs and generics. Driven by health authorities worldwide, pharmaceutical manufacturers are under increasing pressure to implement QbD principles and thereby increase control over product quality. This also impacts excipient supply. More Information & Registration
15. December 2015
The new EU guideline 2015/C 95/02 calls pharma companies to run by March 2016 a detailed analysis of the impact and risks expected by the use of the excipients in product development and manufacturing. We discussed the key points of the guideline with representatives of both the suppliers and the pharmaceutical industry. More
06. September 2015
Pharmaceutical excipients have different functions within a drug formulation, consequently they can influence the manufacturability and/or performance of medicinal products. Therefore, critical to quality attributes should be kept constant. Sometimes it may be necessary to qualify a second supplier, but its product will not be completely equal to the first supplier product. More
09. June 2015
Highlights • Qualification of entire processes based on CQAs of the final product (excipient). • Use of analytical methods (Raman, X-ray- and laser diffraction) with MVDA. • The value of such combined strategy is to produce a better diagnostics of quality. • Evidence-driven diagnostics of which process delivers a more consistent end-product. • Strategy for a risk-based supplier qualification using an analytical data matrix. Read more
27. April 2015
29/04/2015 09:35 - 09:55 - IPEC Europe, Room C Liz Meehan Principal Scientist in Material Attributes and Product Performance - Astra Zeneca http://www.making-pharma.com/seminar/1644/