Onyx Scientific
Comprehensive validation support for expansion
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3,000+ sqm
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2
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MRHA
Onyx Scientific is a leading small molecule Contract Development & Manufacturing Organization (CDMO). The company recently undertook an expansion project at its 3,000+ sq. metre MHRA-accredited Wayfarer Road laboratories facility in Sunderland. As a reputable cleanroom validation and certification service provider, Validair was entrusted to deliver validation support throughout the project. The firm’s decision to partner with Validair has proven to be a wise one.
Background to the project
The validation project comprised two separate phases over a 30-month period. The first phase of the construction project included establishing a Grade D cleanroom suite comprising six separate Good Manufacturing Practice (GMP) laboratories. Our involvement in the Onyx Scientific expansion project began in January 2021 with a thorough review of the User Requirement Specification (URS). We are skilled at creating and reviewing URS documents; deploying this skill as the initial step in
a project always sets a firm foundation for the subsequent validation activities. the Onyx Scientific expansion project began in January 2021 with a thorough review of the User Requirement Specification (URS). We are skilled at creating and reviewing URS documents; deploying this skill as the initial step in a project always sets a firm foundation for the subsequent validation activities.
Project scope
The validation process itself kicked off with Design Qualification (DQ), where our expert team ensured that the cleanroom suite design met the identified requirements. With DQ successful, the Installation Qualification (IQ) procedure validated the proper installation of equipment and systems to ensure that everything complied with the design specification.
The final validation process for phase one of the project is Performance
Qualification (PQ). Here, we assessed and documented the suite’s performance against predefined acceptance criteria. Our experts conducted a series of tests, including environmental microbiological sampling and particle count measurements in simulated operational conditions. This is a diligent approach that ensures a cleanroom suite complies with GMP regulations, making it ready for operational use.
Successful MHRA Inspections
Following the completion of our comprehensive validation activities for Phase 1, the Onyx Scientific Wayfarer Road facility underwent inspection by the Medicines & Healthcare Products Regulatory Agency (MHRA), which proved to be highly favourable. It’s clear that the meticulous Validair validation process successfully confirmed that the cleanroom suite and associated GMP laboratories met regulatory standards.
Validation of additional GMP areas, including a GMP Packing Suite
Recognising Validair’s expertise and the added value we delivered during the validation success experienced with Phase 1 of its expansion programme, Onyx Scientific knew that we would deliver thorough and reliable results again. The company engaged Validair for Phase 2 of its project in 2023. This time it was the validation of additional GMP areas, which included a new GMP Packing Suite.
Our PQ activities for Phase 2, including the GMP Packing Suite, are set to be completed in August 2023. This final qualification phase will ensure that Onyx Scientific’s expansion project is fully validated and compliant with GMP regulations to provide a solid and trusted foundation for its operations.
