A top-tier CBD oil manufacturer approached Orion GMP Solutions for consulting services in their pursuit of meeting European Union Good Manufacturing Practices standards and guidelines potentially enabling export of their products. The scope of services including review of a current manufacturing facility and its suitability to comply with EU-GMP requirements as well as the quality management systems that are used to validate and verify the process has the ability to control and identify instances of loss of control.
Orion approach the project by first understanding the current operations and quality management systems creating a baseline through a process and documentation diagnostic. Once the gaps were understood and documented, Orion provided failure modes effects analysis (FMEA), and a facility design review, and supported quality management systems improvement activities making those systems compliant 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 GMP regulations and guidelines.