Qualified and experienced GMP experts
All cleanroom projects with a requirement for GMP will have oversight from our dedicated regulatory governance team. With over 30 years’ combined experience in GMP & pharmaceutical industries, this level of in-house expertise sets us apart from other cleanroom companies.
We also execute audits of existing facilities and Quality Management Systems, including pre-inspection or mock audits in readiness for a regulatory visit or a customer audit. This service covers both EU GMP and cGMP, governed by the MHRA and FDA respectively.
Regulatory Governance & Assurance Manager
Joan has 30 years' previous experience in Cell and Gene Therapy, Academia, Pharmaceutical Industry, Contract Clinical Research and Hospital Aseptic facilities.
Career summary- 20 years as Head of Production on 6 MHRA licences
- 6 years as Person Designate on HTA Human Application licence
- 20 years front facing regulatory inspection experience in MHRA, FDA, HTA and HFEA inspections
- Quality Management Systems Lead Auditor/Lead Auditor for the Pharmaceutical Industry (IRCA certificated)
- Global Subject Matter Expert for GMP in world leading Contract Research Organisations
- GMP Consultancy including review, design and implementation of Quality Management Systems, audits and mock regulatory inspections, review of existing GMP facilities, layouts for new facilities
GMP & Validation Co-ordinator
Simon has 8 years' experience in the production of radiopharmaceuticals. He understands the implications of GMP on the qualification & validation of a facility. As well as equipment maintenance and calibration, cleaning, and environmental monitoring.
Career summary- 8 years within a fully accredited GMP facility manufacturing sterile pharmaceuticals within a Grade C environment
- 4 years as Supervisor of a production department responsible for national Positron Emission Tomography (PET) tracer supply
- 4 years as site radiation protection supervisor responsible for site staff safety and best practices when working with ionising radiation
- Co-ordination of large-scale overhaul projects of production cleanrooms and equipment
- Generation, execution & review of validation protocols to ensure compliance with MHRA requirements
- Managing maintenance and daily operations of a GMP facility
Ready to start your GMP cleanroom project? Contact us
We are committed to supporting you through successful audits and inspections, now and in the years to come. To learn more about our GMP cleanroom design-build services, contact us.