Project: New Dry Products Facility - 60 Products 200 presentations 3 Billion Tablets and Capsules per year
Location: Croatia
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 60 different products in 200 plus presentations.
The factory was designed to full EU/US pharmaceutical standards and is fully validated to MCA/FDA requirements.
The GMP Group was employed as the Technology Design, Engineering and Validation consultants, throughout the design, construction, procurement validation and start up of the facility. The GMP Group carried out 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 prepared the Validation Master Plan, which was submitted, to the MHRA and FDA for comment. The VMP was written for the total project and 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 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 were carried out to ensure the start up of the facility was 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 prepared all basic SOP’s for the plant and trained client personnel in the SOP’s. The GMP Group managed all validation resources on behalf of the client and assigned tasks to members of the validation team. All protocol templates where prepared by The GMP Group for the use of the validation team, The GMP Group approved all protocols for major systems and equipment