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.
Global compliance and quality assurance manager
Joan has 30 years previous experience in Cell and Gene Therapy, Academia, Pharmaceutical Industry, Contract Clinical Research and Hospital Aseptic facilities. She was front facing regulatory inspections in MHRA, FDA, HTA and HFEA for 20 years.
Global compliance lead
Simon has 8 years previous experience in the production of radiopharmaceuticals within a fully accredited GMP facility manufacturing sterile pharmaceuticals. This gives him a unique understanding on the implications of GMP.
– 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
– 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
Custom-built GMP Cleanrooms
Patient safety is critical in pharmaceutical manufacturing. This is why our GMP cleanrooms are fully compliant with Good Manufacturing Practice guidelines and the provided User Requirement Specification (URS). If you need an MHRA-compliant manufacturing environment, find out how the experts at Angstrom Technology can help.
GMP Cleanroom Qualification
Good manufacturing practice (Eu GMP) described the minimum standard a medicines manufacturer must meet in their production processes. EU GMP Annex 1 details the maximum permitted particle concentrations for classification for ‘at rest’ and ‘in operation’ states for sterile manufacturers.
GMP Cleanroom Training
New in 2023! Personnel working within a GMP facility require regular training on cleanroom practices, hygiene, and contamination control. Our course has been developed by experts to help you with GMP compliance.
REQUEST A CONSULTATION
We are committed to supporting you through successful audits and inspections, now and in the years to come. To learn more about our GMP consultation services or GMP cleanroom design-build assistance, please contact us by clicking the button below.