Wednesday, September 22, 2010
AIChE to Award Lilly’s Seibert, Pfizer’s Garcia-Munoz for Moving QbD Forward
Congratulations to Kevin Seibert and Sal Garcia-Munoz on receiving AIChE's new awards for Excellence in QbD. The drug substance award is sponsored by DynoChem and the drug product award by Pfizer. See the news item at PharmaQbD.com, http://bit.ly/bYBive.
Labels:
Design Space,
QbD
In QbD or elsewhere, experiments are no substitute for thinking
Terry Redman posted an article on PharmaQbD.com recently entitled 'If QbD is the Map, Then PAT Is the GPS' and I posted a reply that I am reproducing here; you can add your own thoughts on the PharmaQbD site if you like.
Analogies are useful when trying to understand new concepts and Terry’s is witty and readable. It’s a shame that these analogies appear to be needed when we are several years down the line with QbD. I tend to think of both maps and GPS in a positive light, although both can be misleading from time to time.
If I had to use travel metaphors to explain QbD and PAT I would say:
- QbD is a way of driving safely and defensively, so that quality targets are met;
- The human / engineer / scientist / organization provides the map, steering, fuel and the motive power;
- Software and hardware tools may allow a change of gears;
- PAT instrumentation is the rear view mirror, telling us what has happened, after it has happened;
- Predictive modeling tools are the windscreen and the headlights, leveraging other information to predict the future, i.e. before it happens. That is what enables design.
You could summarize by saying that measurements, however numerous, sophisticated and timely, are not a substitute for thinking.
Analogies are useful when trying to understand new concepts and Terry’s is witty and readable. It’s a shame that these analogies appear to be needed when we are several years down the line with QbD. I tend to think of both maps and GPS in a positive light, although both can be misleading from time to time.
If I had to use travel metaphors to explain QbD and PAT I would say:
- QbD is a way of driving safely and defensively, so that quality targets are met;
- The human / engineer / scientist / organization provides the map, steering, fuel and the motive power;
- Software and hardware tools may allow a change of gears;
- PAT instrumentation is the rear view mirror, telling us what has happened, after it has happened;
- Predictive modeling tools are the windscreen and the headlights, leveraging other information to predict the future, i.e. before it happens. That is what enables design.
You could summarize by saying that measurements, however numerous, sophisticated and timely, are not a substitute for thinking.
Labels:
CQA,
Design Space,
DOE,
QbD
Sunday, September 19, 2010
AIChE 2010 Pharma and QbD Program Looks Excellent
The 2010 AIChE Annual Meeting (Salt Lake City, 7-12 November) features 12 oral sessions in the QbD Topical Conference and 12 additional oral sessions on other Pharma topics. There's also a QbD Mixer social event on Tuesday 9 November that includes presentation of two new AIChE Awards for Excellence in QbD.
Highlights include the Tuesday morning session on 'Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment', featuring:
Creating a Capabilities Driven Organization: Efficient Design of API Processes
Bret E. Huff, Eli Lilly and Company
You can find the full Pharma program listing here. And you can register for the meeting here.
Highlights include the Tuesday morning session on 'Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment', featuring:
Commercialization and Quality by Design: Towards An Improved Model for Pharmaceutical Development, Launch and Supply
Michael P. Thien, Merck & Co., Inc.
Michael P. Thien, Merck & Co., Inc.
Bret E. Huff, Eli Lilly and Company
You can find the full Pharma program listing here. And you can register for the meeting here.
Labels:
Design Space,
QbD