Project: General Purpose Plant, Bulk API - Bulk API Manufacturing 1000 tons per year

Location: Dagenham, UK Belgium

Validation Consultants

The client manufactured Bulk API’s at the site. The existing General Purpose Plant was purchased as a fully validated facility. The GMP Group was appointed by the client to audit the existing process, facility and validation packages and support documentation. On completion of the GAP analysis that included completing a document check list for each item of equipment (Based on a realistic and pragmatic expectation of what was and should be available within the document system).

The GMP Group produced a Quality plan for bringing the facility to full OQ levels.
The GMP Group where appointed to carryout all detailed engineering, supervision and procurement to bring the plant back into production, together with a VMP and full IQ, OQ, PQ, of 87 major validation packages for major equipment, utilities, HVAC and tank farm.

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 IQ, OQ, & PQ of all new systems and equipment together with the retrospective IQ, OQ & PQ of all existing equipment, which was to be renovated.

The VMP also covered the process validation for the first 2 products to be manufactured on completion of the qualification of the equipment, facilities and utilities.