Global Cleanroom Expertise: Regulatory Governance Team

performance qualification

The regulatory landscape for cleanrooms can be complex. On top of managing the requirements of the ISO 14644 suite of standards, you may also need to comply with cGMP (Good Manufacturing Practice) guidelines and those of industry regulatory bodies. But the experts at Angstrom Technology are committed to supporting you through successful audits. All cleanroom projects with a requirement for cGMP compliance have oversight from our dedicated regulatory governance team.

With over 40 year’s combined experience in cGMP and pharmaceutical industries, this level of in-house expertise sets us apart from other cleanroom companies. In this blog — the first in our Global Cleanroom Expertise series — we explain how we can support your regulatory compliance.

Meet the Regulatory Governance Team

Global Compliance and Quality Assurance Manager	Global Compliance Lead

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 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.

Regulatory compliance services

Our cleanroom systems can be qualified to cGMP, and the required ISO classification. Not only that, but they can also meet any applicable international engineering and building standards and regulations. Our skilled and multi-faceted team can provide the following key services to support your compliance:

Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT)
Validation
Audits of facilities and Quality Management Systems
Gap analysis
Mock regulatory inspections
Bespoke validation studies

Regulatory governance successes

Our team has led high-profile global cleanroom projects to regulatory compliance. There are just a few of their recent successes.

Led cleanroom validation (DQ, IQ, OQ, PQ, FAT, SAT and a wrap-around validation package covering EMS, VHP systems and cryostorage) for a 33-room Cell and Gene Therapy Manufacturing Facility.
Led cleanroom validation (DQ, IQ, OQ, PQ, and all commissioning data) for a 6,500 Cleanroom Facility in their 11,000 square feet Single-Use Bioprocessing Technologies Manufacturing Facility.
Supported numerous clients on the delivery of their projects with regulatory support on all aspects including design, validation, and commissioning
Led cGMP qualification packages for current clients with GMP facilities
Gap analysis for leading clinical research units

Ready to start your cGMP 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 cGMP cleanroom design-build services, request a quote or contact us.

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Jeni Thomas