Orion GMP Consulting Limited was founded by Managing Director Charley Maxwell to provide contract QP and RP services and consultancy support such as training and expert knowledge to pharmaceutical manufacturing and distribution clients.
Orion GMP Consulting draws on the experience of our consultants and their links to the pharmaceutical industry through consulting and QP/RP roles to assist our clients in developing, managing, and continuously improving their quality systems.
QMS development and licence applications
This is one of our core competencies, and we can assist pharmaceutical enterprises in expanding their range and launching in new territories by developing the required licensing and QMS requirements. This includes writing new SOP’s, Quality Manuals and Site Master Files, identifying additional resource requirements and assisting with the necessary licence applications in relevant territories.
We can assist our clients with their entire vendor approval process, from risk assessing potential and current suppliers to initial assessments and right through to performing supplier audits. Audits are conducted against most recognised pharmaceutical standards, and we will assist in making the final recommendations on the selection or rejection of suppliers.
Inspection preparation and follow up
We assist our clients in preparing for competent authority inspections, including working with existing teams to assess readiness levels and to prepare. Where findings have been received, we can assist with completing gap assessments and developing the necessary CAPA action plans to address the findings.
Qualified Person / Responsible services
We have access to consultants who are eligible to act as Qualified Persons (QPs) and Responsible Persons (RP’s), and so we can assist clients with staff augmentation if required.