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Pharmaceutical Manufacturing and Packing Sourcer

Manufacturing a Renaissance

The pharmaceutical industry is proud of its technical innovations in the discovery and development of new medicines, and rightly so – for example, the discovery of penicillin and its development as a drug product revolutionised the treatment of infectious diseases. But the pharma industry has sadly fallen far behind in product manufacturing efficiency and innovation. The polymer and foods sectors especially are constantly driving continuous improvement in manufacturing efficiencies, whereas pharma manufacturing practices have not changed significantly in fifty years.

This inertia has been attributed to constraints by regulatory agencies in what are deemed acceptable manufacturing and quality control practices. Batch processing continues to be the normal practice for medicinal products, due to the visibility and control over quality critical factors such as ingredient lots used and processing parameters. However, things are changing.

Implementation of Quality by Design (QbD) principles in product development is resulting in greater emphasis being placed on demonstrating process control through the monitoring of critical process parameters to confirm satisfactory product quality, instead of relying on the traditional approach of the testing of stratified samples. This approach is now considered as ‘best practice’ by regulatory agencies.

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Robert Harris
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