Project: Dry Products Manufacturing & Packaging Facility

Location: London, UK

Validation Consultants

On completion of a review of the current status of the existing validation of equipment, facilities, HVAC and process utilities, The GMP Group was requested to put together a plan for the requalification of the complete site. This has entailed the survey and preparation of validation packages for approximately 2000 items of equipment in 400 validation packages.

The GMP Group where responsible for the planning and resourcing of the complete project including the planning and resourcing of deviation management and fixing.

The VMP covered the, DQ, IQ, OQ, & PQ of all new systems and equipment together with the IQ, OQ & PQ of all existing equipment, together with the production of a Requirements Traceability Matrix, and a Live Technical File to ensure the ongoing compliance and validation of the manufacturing & packaging facility.

The HVAC and Process Utilities and Manufacturing and Packaging rooms for the site where not able to be qualified to the current standards due to the age of the systems and the expectations of the regulators. The GMP Group are responsible for the engineering design to bring the 35 HVAC systems and 3 Purified Water systems into compliance to allow the validation of the systems.