Process analytical technologies initiative

Hussain AS. The Process Analytical Technology Initiative PAT and the Pharmacopeias. EDQM Spring Conference, Cannes, 3-4 May 2004. http // www.fda.gov/cder/OPS/EDQM.ppt. 

FDA (2002), Process Analytical Technologies Initiative, U.S. Food and Drug Administration. 

T. Kourti, The Process Analytical Technology initiative and multivariate process analysis, monitoring and control. 

H. Leuenberger and M. Lanz, Pharmaceutical powder technology - from art to science the challenge of the PDAs Process Analytical Technology initiative, Adv. Powder Technol, 16(1) 3-25,2005. 

FDA [Online], Office of Pharmaceutical Science (OPS) Process Analytical Technology (PAT) Initiative, Available http //www.fda.gOv/AboutFDA/CentersOffices/CDER/ucm088828.htm, accessed 7 December 2008... 

With the onset of the QbD initiative (see Section 2.3.4), first codified in the ICH Q8 document in 2006, the above-mentioned broader definition of process analytical technology has somewhat evolved into parts of the key elements of the broad definition of QbD, resulting in a partial retraction of the term PAT back... 

The present review illustrates that UV-vis based process analytical technology is widely discussed, but published examples are still scarce. The pharmaceutical industry, driven by the FDA s PAT initiative, can be seen as a forerunner. This is reflected by the observation that many references in this chapter are (co-) authored by representatives from pharmaceutical companies like Glaxo Wellcome and GlaxoSmithKline, ° " ° Astra Zeneca, Novartis and Eli Lilly. ... 

The recent FDA initiative on Process Analytical Technology (PAT) attempts to define a design space for unit operations such as compaction... 

Current and/or planned collaborations with other groups, based on lessons learned are shown in [ ] recommendations for other groups in the initiative are identified in. Abbreviations. PAT, process analytical technology FDA, food and drug administration. 

Since the publication of a very successful First Edition of Pharmaceutical Process Scale-Up, several crucial related FDA documents have been revised. Also, significant new FDA initiative the (the aforementioned Process Analytical Technology or PAT), has had a strong impact on the pharmaceutical industry. 

Hinz, D. C. (2006), Process analytical technologies in the pharmaceutical industry the FDA s PAT initiative, Anal. Bioanal. Chem., 384,1036. 

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