Our Services

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.

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Regulatory governance team

Joan Benson

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.

Simon Rice

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.

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

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

Have you seen our webinar?

“The Building Blocks Of Cleanroom Compliance”

 

On Wednesday 10 April 2024, our Regulatory Governance team hosted our first webinar of 2024, The Building Blocks of Cleanroom Compliance, where we were delighted to welcome over 70 attendees!

The webinar consisted of a 20 minute presentation followed by 10 minutes of Q & A. Topics covered include:

  • When is regulatory compliance necessary?
  • Developing a User Requirement Specification (URS) and why this is important.
  • Pre-project compliance such as layout, process flow, and choosing the correct cleaning & disinfection tools and how they interact with the materials used for building the room.
  • Project compliance throughout all stages of the build process
  • Qualification of the facility using DQ, IQ, OQ & PQ

And much more! Watch the full video and browse the Q&A using the link below!

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GMP Consultancy

Our GMP Consultancy Services are designed to support cleanroom users in navigating the complexities of Good Manufacturing Practice (GMP) requirements. Our team of experienced consultants bring in-depth knowledge and practical expertise to ensure your cleanroom meets the necessary regulatory standards, meets your process requirements and guarantees product quality and safety.

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GMP mock inspection

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.

 

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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.

 

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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.

 

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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.

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