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Is the Desired State in Sight?

Agnes Shanley, Editor-in-Chief
Tuesday, March 05, 2013 17:30 EST

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Agnes Shanley
Agnes Shanley  
3/6/2013 7:19:35 PM
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Re: Desired State = To ISO?
Thanks for writing in.  You must have come to pharma from a different industry.  You can see in some of the slides the fact that pharma's approach to quality is old-fashioned, lab testing of the product.  Other aspects are outdated as well, when compared with the way things are handled in other industries.  So this term was meant to bring some of that "modern product development and manufacturing" thinking to the drug industry. Maybe more people are getting the message, 10 years later.  I'd like to think so. Thanks again!  

Agnes Shanley
Agnes Shanley  
3/6/2013 7:14:57 PM
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Re: Still scratching my head.
Thanks for writing in.  You must have come to pharma from another industry, where some of these concepts have become commonplace.  

Maybe some of the mysteriousness and new terms and acronyms reflect the fact that the drug industry is unique, even though it shares the same needs as other industries (for consistent quality and continuous improvement, as William Botha writes). PAT, for instance, is used widely in many other industries, yet, for the traditionally trained industrial pharmacist, was pretty revolutionary when it was first discussed as being applicable to drug manufacturing. When more people like you from other industries work in pharma, and professionals in the industry are trained in other methods,  the mystery will disappear and these ideas will be common. 

Agnes Shanley
Agnes Shanley  
3/6/2013 7:06:55 PM
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Re: Moving Target
Thanks for writing in.  It shouldn't be unattainable, but it requires a change in mind set. Maybe that change is already happening and more people are adopting a "continuous improvement" approach.

Agnes Shanley
Agnes Shanley  
3/6/2013 7:04:08 PM
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Re: Moving Target
Well said.  Economics should drive efforts.  However, people keep telling me that, despite the patent cliff and all the increasing global competition, fat margins are still insulating some companies from the true impact of market forces (and preventing some of them from investing in new technologies or better ways of doing things that would improve quality). This was a mini poll and responses don't indicate anything statistically significant, but at least it shows that people are aware of what ICH had articulated, and are keeping those goals in mind (and getting better at doing that).  So maybe the glass is half full.  

Girish Malhotra
Girish Malhotra  
3/6/2013 1:01:13 PM
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Re: Moving Target
If I add all the poll numbers, it tells me that the train has no schedule to leav the platform. Question could be is there a train. 

Desired state for the same product is variable depending on who is designing and reviewing. However, designing the best economic process should be the goal. 

Alison Diana
Alison Diana  
3/6/2013 9:14:17 AM
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Moving Target
It's really an unattainable goal, albeit one we should all pursue. The Desired State is a changing goal; once (if?) we get close to it, then it means we need to work to the next stage -- Ultra-Desired State?

Rodney Brown
Rodney Brown  
3/6/2013 8:47:35 AM
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Still scratching my head.
I have to put myself in the group that has no idea what the "Desired State" is, even after looking at the PowerPoint. It seems to be more efficient manufacturing in some nebulous overview, but I am clueless on the details.

jbosavage
jbosavage  
3/6/2013 8:40:59 AM
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Desired State = To ISO?
Is "desired state" similar to ISO 900(1,2,3) in manufacturing? Does this replace another integrated approach to quality, or is it new. THe latter would be surprising to me.

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