Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method

Oct 11, 2018
By Agilent

Register free: http://www.pharmtech.com/pt/implementing

When considering a new analytical technology in the pharmaceutical industry, two key questions always arise: is there a good business case for it, and what are the regulatory consequences? In this talk, we will present the approach that led to the implementation of transmission Raman spectroscopy for content uniformity testing at a pharmaceutical company. We will show that it is not only the financial benefit, but also the stakeholder enthusiasm that convinced management of the need to invest in new technology for a standard test requirement.

 

The approach for rolling out transmission Raman spectroscopy to all sites at Grünenthal Pharma involve the development of procedures and templates steered by a Center of Expertise (COE). In the COE the models developed and the standard approach for sample preparation—including required equipment— is determined alongside the validation procedure. The regulatory strategy, including templates, is also determined here.  With this approach, Grünenthal Pharma intends to ensure a global standard and enable the ability to support and transfer methods from one site to all others.

Key Learning Objectives:

In this webcast you will learn about:

  1. The reasons for using transmission Raman spectroscopy for content uniformity and how it works in conjunction with established liquid chromatography (LC) methods.
  2. The approach that led to the implementation of transmission Raman systems for content uniformity testing at Grünenthal Pharma.
  3. How roll-out of these new systems relies on a Center of Expertise for model development, sample preparation, validation procedures, and regulatory strategy.
  4. How the company intends to ensure a global transferable standard in content uniformity testing using transmission Raman spectroscopy

Speaker: Meike Römer, Ph.D., Manager Process Analytical Technology, Grünenthal Pharma, Germany

Time and date:
Europe: Thursday, Oct. 11, 2018 at 2pm BST/ 3pm CEST
North America: Thursday, Oct. 11, 2018 at 11am EDT/ 8am PDT/ 10am CDT
After final airing, webcast will be available on demand until Oct. 11, 2019.
 

Sponsor: Agilent Technologies

Register free: http://www.pharmtech.com/pt/implementing

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