Quality at The Interface: Assuring Safe and Effective Product From Your Contract Manufacturing Organisation

Time: 12:10 pm - 12:30 pm

Date: 30 April 2019

30-april-2019 12:10 30-april-2019 12:30 Europe/London Quality at The Interface: Assuring Safe and Effective Product From Your Contract Manufacturing Organisation

Safe, effective product, consistent with specification, must be our goal. If we make the product ourselves we are in control.  But, if we entrust the manufacture to others, how can we be sure that the product, that we are legally responsible for, has been made in accordance with our requirements and the decisions that we… Read more »

Making Pharmaceuticals

Synopsis

Safe, effective product, consistent with specification, must be our goal.

If we make the product ourselves we are in control.  But, if we entrust the manufacture to others, how can we be sure that the product, that we are legally responsible for, has been made in accordance with our requirements and the decisions that we have made during the product life cycle?

This presentation looks at the effectiveness of supplier qualification, quality & technical agreements and source information files, such as the product specification file, that support the necessary controls for the manufacture of safe and effective investigational medicinal product.  The approach may be equally relevant for other healthcare sectors.

Speakers

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