Cogent Skills produces Guidelines
for Regulatory Considerations of Pharmaceutical Continuous Manufacturing
The Guidelines are an output of REMEDIES (RE-configuring MEDIcines End-to-end Supply) an Advanced Manufacturing Supply Chain Initiative project, headed up by GlaxoSmithKline (GSK) with research led by the University of Cambridge’s Institute for Manufacturing.
It was a broad-based collaboration examining how the multi-billion pound global medicines manufacture and supply sector can be reshaped to meet the needs, expectations and budgets of the 21st Century. One of the strands focused on how to develop and implement continuous manufacturing processes, to make robust medicines more flexibly, cheaply and repeatably, and for a wider range of products.
Cogent Skills was part of this collaboration examining the skills implications of continuous manufacturing processes for skills and regulatory compliance.
As part of this analysis, following discussions with the MHRA, we identified a knowledge gap relating to regulatory expectations for continuous manufacturing.
As a result, working with various Remedies project partners and the Medicines and Healthcare products Regulatory Agency (MHRA), Cogent Skills compiled three guidelines including GMP Guidelines relating to Continuous Manufacturing , Quality by Design (QBD) and Development of a Continuous Manufacturing Process – Regulatory Considerations.
These guidelines have been incorporated into the Britest e-learning platform for the Remedies project.