Project: New Dry Products Manufacturing & Packaging Facility - 80 different products in 150 plus presentations. 1 billion Tablets per year
Location: Portugal
Engineering Design & Validation Consultants
The GMP Group began working with the client production team to develop a new dry product facility to manufacture up to 80 different products in 150 plus presentations. The factory was designed to full EU pharmaceutical standards and is fully validated to MHRA requirements.
The GMP Group was employed as the Technologists, Designers, for concept, detailed design, Validation and Project Managers, throughout the design, construction, procurement validation and start up of the facility.
The GMP Group prepared the Concept Design, the full engineering design for tender packages, and the Validation Master Plan. 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. Only stand alone computer validation packages.
Throughout the project The GMP Group worked with the production personnel responsible for the different areas of the production processes, to ensure that all user requirements where satisfied. Start up of the facility was achieved in accordance with the co co-ordinated programme.
As part of the brief The GMP Group prepared a co-ordinated 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 personnel in the SOP’s. A key procedure was for the GMP library, set up by The GMP Group and operated from the start of the concept design to the start up and is now in full operation with the facility.
The GMP Group managed all validation resources on behalf of 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