Making Pharmaceuticals Presentation

“GMP Quality Oversight of Your Investigational Medicinal Product”

Julie recently presented at the Making Pharmaceuticals event highlighting a sponsor’s responsibility when outsourcing the manufacture of Investigational Medicinal Product (IMP). If you would like to download a copy of the presentation, please complete the form below.

Are you working towards GMP manufacture of an IMP?

Limited in-house GMP experience may cause a delay to implementing a suitable quality system for sponsor GMP oversight. We can point you in the right direction by providing trackers and some “on-the-job” support. 

Ideally, structured ways of working are implemented in parallel with selection of your manufacturing partners. Archiving of technical reports and GMP documents into a structured repository, as soon as documents are completed, provides immediate traceability to product knowledge and the GMP controls implemented by your manufacturer partner.

At JWQC, we can support work within our established processes whilst transitioning and adapting the processes to your system, enabling you to gain the experience of documenting aspects of GMP oversight whilst also reducing your initial investment.