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Importance of including validation from an early stage

Validation is a regulatory requirement for all GMP cleanrooms to ensure the facility is completed to the required standards and is safe for its intended use.

Bouygues Energies & Services have vast experience in validation of cleanrooms, HVAC Systems and High Purity Utility Systems in the Pharmaceutical, Biotech, Medical Device and NHS sectors satisfying the client’s user requirement and regulatory requirements of the FDA, MHRA and other applicable regulatory bodies.

An accreditation that has been gained by Bouygues Energies & Services from the NQA for the compliance of their quality management systems against the requirements of BSEN ISO 9001 for design, installation, commissioning and validation of cleanrooms, HVAC Systems and High Purity Utility Systems.

Benefits of including Validation from the design stage

Bouygues Energies & Services believe if validation is included from the design conception stage, the project team can assure that the site is compliant throughout the project lifecycle and on to accreditation and licensing by the regulatory bodies. 

“We follow stringent in-house Validation Policies and Procedures for Protocol Preparation, Execution, Reporting and Deviation Management." Said John Ellerton, Validation and Regulatory Affairs Manager at Bouygues Energies & Services

A few example of processes applied by Bouygues Energies & Services are:

•    Validation requirements integrated into the project lifecycle from outset.
•    Generation of project URSs, Validation Master Plans and Validation Summary Reports for the client
•    Client’s regulatory body (MHRA, FDA, etc) involved at the design stage to rubber-stamp the design before the commencement of the build.
•    Validation team formed with client validation, quality, production and engineering departments to manage the validation process collaboratively”

How can this ensure the site is completed to regulatory requirements?

To ensure the site is fully compliant with regulatory requirements Bouygues Energies and Services Validation Manager is present at site audits by the regulatory bodies during the project lifecycle and post facility handover for licence approval.

John Ellerton stated “By early validation involvement we are able to give a streamlined service and a high level of assurance of a right first time approach to facility handover, compliance, subsequent licence approval and a guarantee of client satisfaction. We are a one stop shop for the design, construction, commissioning and validation of licenced GMP facilities”.

The companies validation procedures and protocol templates, which are part of the companies Integrated Management System, are subject to continuous improvement. The MHRA have also given Bouygues Energies and Services credit for the standard of the validation documents, but still made some suggestions where further improvements could be made. These have been implemented. And the company continue to make improvements.

The Unit Manager Inspectorate Strategy and Innovation at MHRA London carried out two design review meetings with Bouygues Energies and Services and a client on the proposed design of their new facility. "We took away a number of actions from the first meeting and when we represented the design at the second meeting he said, “I’m happy with that, now go and build it”. We did and the facility was licenced at the first time of asking and won an award for the most innovative facility that year.”
 

To find out more about early-stage engagement CLICK HERE
 

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