New Challenges and Opportunities for Pharmaceutical Manufacturing Science

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
AIChE Annual Meeting
October 29, 2012 - 9:00am-9:30am
New Challenges and Opportunities for Pharmaceutical Manufacturing Science

Vincent L Vilker and Mansoor A Khan,  CDER/FDA

The increasing sophistication of modern drug products is leading to unprecedented challenges and opportunities for pharmaceutical manufacturing.  At the same time, scientific and technological advancements in analytical instrumentation, coupled with implementation of the principles embedded in quality by design, enable the improved process monitoring and control that lead to better and more consistent product quality.  ICH Q8(R2), the first of three International Conference on Harmonization (ICH) Guidance for Industry that spell out the concepts of Quality by Design, states that critical formulation attributes and process parameters should be identified through an assessment of the extent to which their variation can have impact on the quality of the drug product.  In this presentation, examples will be given where modern instrumentation and manufacturing practices are required to maintain the critical formulation attributes of several drug products that have unique physicochemical and/or biological properties. Examples may include properties such as very low solubility, polymorphic solid states, poorly defined macromolecular size distributions, or where there is a tendency to become unstable in the formulated product.

Professional Development Hours
0.5 PDHs
You will be able to download and print a certificate for these PDH credits once the content has been viewed. If you have already viewed this content, please click here to login.

Would you like to access this content?

No problem. You just have to complete the following steps.

You have completed 0 of 2 steps.

  1. Log in

    You must be logged in to view this content. Log in now.

  2. Purchase Technical Presentation

    You must purchase this technical presentation using one of the options below.
    If you already purchased this content recently, please click here to refresh the system's record of ownerships.


Credits 0.5 Use credits
List Price $25.00 Buy now
AIChE Members $15.00 Buy now
AIChE Undergraduate Student Members Free Free access
AIChE Graduate Student Members $15.00 Buy now
Related Topics: