Pharmaceutical processes, process analytical technology

Hussain, A. S. (2001), Emerging science issues in pharmaceutical manufacturing Process analytical technologies, paper presented at the Science Board Presentations to FDA, Rockville, MD. 

U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Process Analytical Technology (PAT) Initiative, assessed on 12/20/2007, available www.fda.gov/cder/OPS/PAT.htm. 

R. Schadt, Process analytical technology - changing the validation paradigm. Pharmaceutical Rev. 7(1) 58-61, January/February (2004). 

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. ... 

T.R.M. De Beer, W.R.G. Baeyens, J. Ouyang, C. Vervaet and J.R Remon, Raman spectroscopy as a process analytical technology tool for the understanding and the quantitative in-line monitoring of the homogenization process of a pharmaceutical suspension. Analyst, 131, 1137-1144 (2006). 

The first demonstration of solid state fluorescence of API dates back to 1961, while its in-line use for final drug product manufacturing was not demonstrated until recently." While in its infancy as a process analytical technology for real-time monitoring and product parametric real-time release, the applications identified and in some instances demonstrated include (i) blend endpoint API content nniformity detection " (ii) segregation monitoring or API content at various process critical control points and (iii) at-line tablet content uniformity determination. The fundamentals of solid-state luminescence spectroscopy for pharmaceutical solids has been covered by Brittain."... 

A.S. El-Hagrasy, F.D Amico and J.K. Drennen III, A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part I D-optimal design for characterization of powder mixing and preliminary spectral data evaluation, J. Pharm. Sci, 95(2), 392 06 (2006). 

M. Blanco, M. Alcala, Content uniformity and tablet hardness testing of intact pharmaceutical tablets by near infrared spectroscopy. A contribution to process analytical technologies. Anal. Chim. Acta, 557, 353-359 (2006). 

Before selecting a process analytical technology to implement, it is helpful to understand the capabilities and limitations of the technology. Good introductions to NIR spectroscopy and instrumentation can be found in Chapter 5, and to chemometric methods in Chapter 12. NIR pharmaceutical applications are covered in Chapters 13 and 14. Additional information on NIR techniques and applications can be found in Williams, ... 

H. Wu, M.A. Khan and A.S. Hussain, Process control perspective for process analytical technology integration of chemical engineering practice into semiconductor and pharmaceutical industries, Chem. Eng. Comm., 194, 760-779... 

The chapter is organized as follows. First, to establish a common language, we define some common terms from both a pharmaceutical and an engineering perspective. Subsequently, we review model-based design and optimization as a framework for product and process development and optimization, process scale-up, and continuous improvement activities. The role of process and analytical technology (PAT) methods and principles in this framework is discussed. Finally, the main areas requiring effort are identified. 

ASTM International. Committee E55 on Pharmaceutical Application of Process Analytical Technology. http //www.astm.org/cgi-bin/SoftCart.exe/ COMMIT/COMMITTEE/E55.htm E+mystore. 

Process analytical technology is consistent with the quality systems approach in that it is based on science and engineering principles for assessing and mitigating risks related to poor product and process quality. In the PAT guidance, the FDA indicates that the desired state for pharmaceutical manufacturing may be characterized as follows ... 

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

Sukowski, L., and Ulmschneider, M. (2005), In-line process analytical technology on qualitative NIR modelhng An innovative approach for the pharmaceutical quality control, Pharmlnd, 67(7), 830-835. 

Robert P. Cogdill, Duquense University Center for Pharmaceutical Technology, Pittsburgh, Pennsylvania, Case for Process Analytical Technology Regulatory and Industrial Perspectives... 

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