Multi-state license holder approached Orion GMP Solutions for consulting services relating to a new facility build-out in the newly legalized State of West Virginia. This project would require full GMP facility design as well as compliant operations to State regulatory requirements.
Orion provided the client with our greenfield “Quality by Design” approach to GMP facility design and the implementation of Good Manufacturing Practices. This scope of services encompassed the entire operation and required a risk-based approach to ensure product safety. Orion was able to help the client map the entire process from incoming materials to final products and determine all necessary controls and protocols to meet GMP standards and guidelines.
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.