This paper and supporting template identifies, shares and enhances best practices and standards, improves risk controls and increases the speed of learning. It discusses a general process designed to provide a risk assessment framework and contains a ready-to-use template. This highlights the complexity of commercial-scale manufacturing as well as considering the areas to assess, potential questions to ask while assessing them, and the other parties who may have pertinent input to the overall risk assessment.
The template can form the basis for discussions between a contract manufacturer and client, or between production and development departments. The aim is to address the following questions when evaluating the CGT manufacturing process: What could go wrong? What controls are in place and are they enough? What did we learn from this?