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QA/QC

 

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Revolutionising Raman with the transmission technique

3 July 2015 | By Julien Villaumié and Hilary Jeffreys, Actavis

All regulatory agencies require that manufacturers accurately determine the amount of drug in a medicinal product so that the product can be deemed fit for patients. This forms part of batch release testing performed by Quality Control (QC) laboratories. The drug assay and/or content uniformity of the dosage units is…

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Reducing microbial contamination via sterile risk assessment

20 April 2015 | By Guenther Gapp, Lachman Consulting Ltd/Independent Consultant

Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools…

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Real-time biological particle counting in environmental monitoring

20 April 2015 | By

The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…

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The scope of PAT in real-time advanced control of tablet quality

20 April 2015 | By Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran: Rutgers University

Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires proactive, corrective actions on the process/raw material…