Regulatory compliance

Our process engineers are experienced in designing and delivering research facilities such as this hepatitis B vaccine production suiteMany NHS hospital pharmacy suites in the UK require upgrading to meet the latest standards and current Good Manufacturing Practice (cGMP). Added to this the regulatory authorities will not accept that cGMP has been complied with unless the production process has been fully validated.

Our process engineering specialists at GRC Mott MacDonald offer comprehensive services for both new build and refurbishment projects in the healthcare sector including project definition, facility design including room layout, equipment and HVAC, construction, installation and all the testing and supporting documentation to gain regulatory compliance from the MHRA through proper validation of the facilities.

We have a broad range of experience in designing and building research and development laboratories for products such as vaccines, blood and sera, biological products, medical devices, solid dosage forms, highly potent products and cytotoxic material. We also have experience in a range of modular laboratories for TSE research, sterility testing, microbiological, cytotoxic and bio-therapeutic purification facilities.

All this means that we can deliver a validated and operational pharmacy suite with minimum disruption to the work of an existing NHS unit. In the case of new build, by ensuring proper management and control, we aim to deliver the new facility to specification, on budget and on time.