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NIR inspection of each tablet that exits a tablet press

In the pharmaceutical industry, waste represents at least 25% of the cost of quality. In 2004, the Food and Drug Administration (FDA) published a guide to promote the implementation of Process Analytical Technologies (PATs) in the pharmaceutical industry. This would allow better quality control (QC) and monitoring directly on the production line.

FDA

The FDA has encouraged manufacturers to use the PAT framework to develop and implement effective and efficient innovative approaches in pharmaceutical development, manufacturing and quality assurance, including continuous real-time quality assurance.

Typically, a limited number of tablets are randomly sampled within a batch for routine analysis. For a batch of a few million tablets, usually only between 10 and 30 are tested.2 The batch is then put in quarantine until QC results are obtained, which generates storage costs and reduces the company’s flexibility to respond to customer’s requirements. If the number of detected faulty tablets is higher than the Acceptance Quality Level, the batch will be manually sorted, reworked, or completely rejected and remanufactured – all of which lead to significant temporal and financial losses.

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