Practical Application of Q8 and Q9 Principles in Pharmaceutical Development

2010 AIChE Annual Meeting
AIChE Annual Meeting
November 10, 2010 - 7:00pm
The presentation “Practical application of Q8 and Q9 principles in pharmaceutical development” gives an overview of the current practice in pharmaceutical development within the Oral Solid Dosage form Development department of Abbott in Weesp, the Netherlands. The presentation starts at the point where the prototype formulation, the Target Product Profile and Critical Quality Attributes are known and focuses on process development using risk based approaches. The use of the broad experience of the development and production of similar process and / or formulations is the start of the process development. A cause and effect analysis (brainstorm session) was performed with a group of scientists and engineers, maximizing the amount of knowledge. After prioritizing the results, the potential critical (process) parameters were known. These parameters formed the basis for developing new scientific knowledge. Risk analysis performed at several stages during the development process gives a presentation of the progress of the development, and the identification of Critical Process Parameters. Design Space and Operating Range was defined for controlling the Critical Process Parameters based on scientific knowledge.
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.
Presenter(s): 

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.

Pricing

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 Free Free access