http://blog.pharmtech.com/2008/10/29/going-public-niptes-new-design-space-project/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2008/10/29/going-public-niptes-new-design-space-project/comment-page-1/#comment-9796 Laura Provan Mon, 03 Nov 2008 15:53:42 +0000 http://blog.pharmtech.com/?p=502#comment-9796 Some clarification is in order here. Contrary to the original posting, USP is not an "agency" like FDA. USP is not part of the government -- it's a private, independent, non-profit organization that sets standards for all prescription and OTC drugs in the United States. FDA is the government regulator and is charged with enforcing adherence to USP standards. And, while USP does have many internationally respected scientists on staff, I think the posting is probably referring to our volunteer experts, who are not USP employees. They are employed by, e.g., industry, government, research centers, consultancies, etc., but in their work at USP they are not acting as agents of their employers, but as scientists volunteering their time and expertise. The whole idea behind USP's standards-setting process is the open, public collaboration and information sharing from which the best science emerges. Some clarification is in order here. Contrary to the original posting, USP is not an “agency” like FDA. USP is not part of the government — it’s a private, independent, non-profit organization that sets standards for all prescription and OTC drugs in the United States. FDA is the government regulator and is charged with enforcing adherence to USP standards. And, while USP does have many internationally respected scientists on staff, I think the posting is probably referring to our volunteer experts, who are not USP employees. They are employed by, e.g., industry, government, research centers, consultancies, etc., but in their work at USP they are not acting as agents of their employers, but as scientists volunteering their time and expertise. The whole idea behind USP’s standards-setting process is the open, public collaboration and information sharing from which the best science emerges.

]]> http://blog.pharmtech.com/2008/10/29/going-public-niptes-new-design-space-project/comment-page-1/#comment-9501 Pradeep Suresh Thu, 30 Oct 2008 18:52:25 +0000 http://blog.pharmtech.com/?p=502#comment-9501 This would be a great initiative since the research community often hears about and sees results from industrial case studies relevant to the use of design spaces, control spaces, QbD and their success with the FDA, but the details are always behind the scenes. It is not intuitive as to why this problem is difficult to tackle if it has been solved in particular industrial cases. Another point of inquisition is why the FDA cannot offer more precise guidelines for abiding by QbD if it has encountered successful projects from industry. Though the competitive edge of the company involved is at stake, it would better the standards of the entire industry. This would be a great initiative since the research community often hears about and sees results from industrial case studies relevant to the use of design spaces, control spaces, QbD and their success with the FDA, but the details are always behind the scenes. It is not intuitive as to why this problem is difficult to tackle if it has been solved in particular industrial cases. Another point of inquisition is why the FDA cannot offer more precise guidelines for abiding by QbD if it has encountered successful projects from industry. Though the competitive edge of the company involved is at stake, it would better the standards of the entire industry.

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