West Coast food producer engaged Orion to provide GMP advising services in their efforts to convert part of operation to cannabis including the complete build out of a GMP enabled facility and wanted to pursue EU-GMP compliance for the objective of exporting.
Orion provided the client with an initial process diagnostic to analyze all the components of their quality system to fully understand the gaps that existed in the operation. Once the gaps were understood Orion provided a gap analysis, Failure Modes Effects Analysis (FMEA), and a facility design review complying to EU-GMP.
At the close of the engagement with Orion GMP Solutions, the client was operating a GMP enabled facility with compliance reliant on internal performance and adherence to Orion provided project management plans to fully meet EU-GMP regulations and guidelines.