PAT & QbD SUPPLEMENT


A BASIS FOR INNOVATION AND CONTINUOUS IMPROVEMENT OF PROCESS UNDERSTANDING AND CONTROL IN


PHARMACEUTICAL PRODUCT DEVELOPMENT


Magida Zeaiter GlaxoSmithKline


Spectroscopic techniques such as Near Infrared, Ultra-Violet, Raman and Fluorescence have been widely used as Process Analytical Technologies in pharmaceutical industries for rapid and less expensive measurements of quality. The increased benefit of these PAT tools is reflected in their use for real-time measurements of product quality during manufacturing, providing online inspection of intermediate and final products.


PAT tools are implemented in the pharma - ceutical industry as part of the Quality by Design approach. They aid process development and optimisation by providing a better understanding of the process changes during manufacturing. For critical quality attributes, these techniques are used as a part of the continuous verification during manufacturing, reducing in-process checks and increasing quality control by providing 100 per cent inspection in real-time. Examples of applications of PAT tools in the pharmaceutical industry will be given, with an emphasis on their


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European Pharmaceutical Review Volume 16 | Issue 3 | 2011


contribution to the Quality by Design approach implementation as a means for process understanding, continuous improvement and control. Pharmaceutical industries have been


increasingly evolving to adopt the regulatory risk-based approaches by using cutting edge scientific and engineering principles in order to improve understanding and control of the formulation and manufacturing process. Quality by Design (QbD) as defined by the FDA1 is a risk based approach to demonstrate high knowledge of, and confidence in, the


performance and efficiency of manufacturing processes to meet the expected product quality. Hence, quality should be built into the product by design through: (i) identifying the critical attributes and their relation to safety and efficacy, (ii) understanding to what extent the variability of these critical attributes and process parameters impact product quality, in order to be able to define and justify a control strategy. There are different tools that could be


used to provide this knowledge and under - standing, e.g. experimental designs, Process Analytical Technologies (PAT), risk and quality management tools, experienced knowledge, etc. Therefore, regulatory agencies consider PAT to be part of the QbD approach, one of the systems for designing, analysing and controlling manufacturing through timely measurements of critical process parameters and critical quality and performance attributes of raw materials,


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