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THE PHARMA REVIEW (NOVEMBER DECEMBER 2012)

Overview of Process Analytical Technology in Pharmaceutical Product Development

Darshana Parmar1, Rashmin Patel1, & Mrunali Patel2

Introduction:
 
Quality cannot be tested into products; it should be built- in or should be by design. PAT is an approach to monitor manufacturing (and other) processes on a continuous rather than discrete basis. Traditionally, quality assurance (QA) monitors the safety and cleanliness of a production facility at all stages, but examines product only at end (or predetermined interim) - stage. If the final sampling process indicates a contamination, dosage error or other problem, the affected batch is destroyed (or reprocessed) and the cause is identified and corrected to avoid future problems. The procedure is not unlike taking a snapshot photograph of an event – a single moment is frozen in time for detailed observation and analysis. PAT replaces the photograph with a streaming video. A process is monitored on a continuing basis (as well as at end-point) to instantly detect and correct any problems.

 

 

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