PAT


SUPPLEMENT


CHALLENGES IN DEVELOPMENT AND IMPLEMENTATION OF


SPECTROSCOPIC TECHNIQUES AS PAT ANALYSERS


Ravindra Dhumal and Tim Gough Centre for Pharmaceutical Engineering Science, University of Bradford


Implementation of PAT systems in pharmaceutical manufacturing involves monitoring and controlling critical process parameters (CPP) influencing the critical quality attributes (CQA) in the product. PAT analysers consist of measurement systems designed to measure these CPP’s at the correct location and at the correct time. The data monitored by PAT analysers is utilised as feedback to make real-time decisions in order to maintain consistent process performance and product quality. This review will focus on the challenges encountered during development and implementation of spectroscopic techniques as PAT analysers in pharmaceutical manufacturing.


Process analytical technology (PAT) has become a dominant issue in pharmaceutical manufacturing in recent years as a result of initiatives by regulatory bodies such as the FDA1 and EMEA2


. It has been the subject of numerous


articles, reports and conference publications as the regulators, industry, suppliers and academia have attempted to tackle numerous method developmental and implementation issues. Despite all these efforts, PAT is still in the early development stage in pharmaceutical manufacturing industry. Efforts have mainly focused on topics such as the feasibility of


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“Various analytical techniques are considered to be PAT analysers, with spectroscopic techniques being the most popular ”


various potential analytical technologies, regulatory aspects and specific method developments. Although Process Analytical Chemistry (PAC) has existed for several decades in the chemical and other allied industries, the nature of pharmaceutical manufacturing


presents new challenges in terms of regulation, risk, complexity and stringent demand on the limits of detection3


. In addition, the application


of PAT into manufacture places new demands on existing industrial infrastructures. A significant amount of research along with strategic investment is required in order to develop, deploy and maintain the analytical methods associated with PAT. Various analytical methods and advanced


data analysis techniques are being investigated as PAT analysers based on both processing and the material properties to be monitored in the final or intermediate product. This article will review the challenges involved in selecting and implementing various PAT analysers. PAT analysers consist of measurement systems designed to measure Critical Process Parameters (CPP) which influence the Critical Quality Attributes (CQA) at the correct location at the correct time. PAT tools should be able to monitor, measure, analyse and control the


European Pharmaceutical Review 9 Volume 16 | Issue 6 | 2011


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