PAT initiative

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... 

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. ... 

Evaluation and Research (CDER), Office of Regulatory Affairs (ORA) and the Center for Veterinary Medicine (CVM), which was titled the PAT initiative. 

In its consultation with industry the FDA has been careful to ensure that the PAT initiative is seen as a win-win both by industry, who will have to change their ways of working with the regulators, and by the FDA who will have to make the initiative workable [44,45]. There are predicted to be gains in quality, safety and efficiency, depending on the nature of the product. These are likely to come from... 

It would be wrong to give the impression that the PAT initiative is confined to the FDA. The FDA has increased its collaboration with international health and regulatory partners, including the International Conference on Harmonisation for the Technical Requirements for Registration of Pharmaceuticals (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Veterinary Medicinal Products (VICH). 

Although not within the scope of this chapter, it is worth noting that the PAT initiative also involves the development of rapid microbiological methods [46], the word rapid in this context being the analogue to process analytical for chemical and physical measurements. The scope of microbial testing within this initiative includes... 

Leuenberger H, Lanz M. Pharmaceutical powder technology-from art to science the challenge of FDA s PAT initiative. Adv powder Technol 2005 16(l) 3-25. 

Rubinovitz R. Diverse measurements through NIR. Pharm Formul Qual 2004 6b. Lewis EN, Schoppelrei J, Lee E. Near IR chemical imaging and the PAT initiative. Spectroscopy 2004 19(4) 26-32. 

Leuenberger H, Lanz M. Pharmaceutical Powder Technology-from Art to Science The Challenge of the FDA s PAT Initiative. Advanced Powder Technology. 2005 16(1). In Press Pre-Print available at http //www.pharma.uni-bas.ch / technology/index.html... 

In addition to readjusting the focus of this book to show the importance of the PAT initiative for pharmaceutical process scale-up, there have been several major revisions and additions. 

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

Pharmaceutical Powder Technology—Building the Pyramid of Knowledge and the Challenge of FDA s PAT Initiative... 

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