Project: New Dry Products Manufacturing & Packaging Facility - 51 Products 2 Billion Tablets and Capsules per year

Location: Serbia

Engineering Design & Validation Consultants

The GMP Group began working with the client design team to develop a new dry products facility to manufacture up to 51 different products in 200 plus presentations. The factory was designed to full EU/US pharmaceutical standards and is fully validated to MHRA/FDA requirements.

The GMP Group is employed as the Technology Design, Engineering and Validation consultants, throughout the design, construction, procurement validation and start up of the facility.

The GMP Group are about to start the Concept Design for the factory and prepared the Technological Project (detailed engineering) to allow tenders and bids to be obtained for all equipment, cleanrooms, HVAC, utilities, BMS and specialist water systems.

The GMP Group developed and prepared the Validation Master Plan; the VMP included all manufacturing equipment, facilities, utilities and HVAC systems. PLC’s and computer systems supplied as part of the equipment.

Throughout the project The GMP Group worked alongside and with the client validation and start-up teams responsible for the different areas of the production processes. This ensured that all documentation, factory testing and writing and approval of protocols is carried out to ensure the start up of the facility is achieved in accordance with the coordinated programme.

As part of the brief The GMP Group prepared a coordinated project plan that linked all of the activities contained within the VMP to the design and construction of the facility and the equipment procurement.

The GMP Group are contracted to prepare all basic SOP’s for the plant and train the client personnel in the SOP’s. The GMP Group will manage all validation resources on behalf of the client and assigned tasks to members of the validation team. All protocol templates are to be prepared by The GMP Group for the use of the validation team.