Project:Â Dry Products Manufacturing & Packaging Facility - 100+products, 2billion tablets and capsules

Location:Â London, UK

Engineering Design & Validation Consultants

This client was one of the largest generic manufacturer to the UK Health Service. They lost their licence to manufacture and package secondary pharmaceutical products at their London sites.

The GMP Group was requested to assist in the reinstatement of the license. The GMP Group prepared all concepts, detailed designs for HVAC and engineering services and a VMP for approval of the MHRA prior to qualification and validation of equipment, facility and processes.

The GMP Group where responsible for the complete decontamination of the facility prior to the refurbishment which included all new Cleanroom, HVAC, engineering services, together with the installation and validation of the equipment.

The VMP covered the DQ, IQ, OQ, & PQ of all new systems and equipment together with the DQ, IQ, OQ & PQ of all existing equipment, which was to be renovated. The DQ on the refurbished equipment was carried out based on the refurbishment specifications.

The VMP also covered the process validation for the first 12 products to be manufactured on completion of the qualification of the equipment, facilities and utilities.

The GMP Group were responsible for retraining the staff in the use of the basic cGMP
SOP’s written to bring the facility back on line.

The MHRA have now approved the sites for manufacture and packaging of the pharmaceutical products detailed in The GMP Group VMP.