Intro

How We Implemented a Quality focused approach to the manufacture of a product

The Challenge

It is clearly understood by developers of cell therapies that a cell therapy needs to be shown to be safe and efficacious to obtain regulatory approval for a clinical trial. What is less clearly understood, is the complex quality management requirements that a regulator will expect to see to support the safety and efficacy claims when they perform their assessment.
Good manufacturing practises (GMPs) are a set of principles and guidelines which set out how products should be manufactured; controlled in accordance with quality standards, to ensure consistency and minimise risks. GMP regulations address issues including cleanliness, staff competence and training, record keeping, equipment verification, process validation and complaints procedures. However, just because something is consistent, doesn’t mean that it will not pose a risk to your product, and thus it is important to ask the right questions.