Case for Process Analytical Technology: Regulatory and Industrial Perspectives

Process analytical technology (PAT) has become an important part of the pharmaceutical manufacturing industry in the recent years. The Food and Drug Administration (FDA) initiative to implement a modern, risk-based framework for regulation and oversight of pharmaceutical manufacturing has been a major driving force for the increase popularity of PAT. This article provides an overview of PAT in the pharmaceutical industry, summarizes FDA initiatives, and presents a basic plan for PAT implementation. Keywords: process analytical technology (PAT); food and drug administration (FDA); pharmaceutical industry; quality management; lean manufacturing

[1]  Deborah L. Illman.  CPAC: An industry—university cooperative research center for process analytical chemistry , 1986 .

[2]  James K. Drennen,et al.  Statistical Experimental Design for Pat Method Development , 2005 .

[3]  James K. Drennen,et al.  The Financial Returns on Investments in Process Analytical Technology and Lean Manufacturing: Benchmarks and Case Study , 2007, Journal of Pharmaceutical Innovation.

[4]  Mel V Koch.  Optimizing the impact of developments in micro-instrumentation on process analytical technology: a consortium approach , 2006, Analytical and bioanalytical chemistry.

[5]  Dirk C Hinz,et al.  Process analytical technologies in the pharmaceutical industry: the FDA’s PAT initiative , 2006, Analytical and bioanalytical chemistry.

[6]  Dennis Sandell,et al.  Development of a Content Uniformity Test Suitable for Large Sample Sizes , 2006 .

[7]  Markus Haider,et al.  Process analytical chemistry—future trends in industry , 2003, Analytical and bioanalytical chemistry.

[8]  James K. Drennen,et al.  Process analytical technology case study, part III: Calibration monitoring and transfer , 2005, AAPS PharmSciTech.

[9]  Philip Lunney,et al.  A Prevention Based Strategy for Quality Control Using Pat , 2005 .

[10]  Ronei Jesus Poppi,et al.  Figures of merit for the determination of the polymorphic purity of carbamazepine by infrared spectroscopy and multivariate calibration. , 2004, Journal of pharmaceutical sciences.

[11]  J. Drennen,et al.  Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release , 2005, AAPS PharmSciTech.

[12]  A. Lorber.  Error propagation and figures of merit for quantification by solving matrix equations , 1986 .

[13]  James K. Drennen,et al.  Process analytical technology case study part I: Feasibility studies for quantitative near-infrared method development , 2005, AAPS PharmSciTech.