Project: Dry Products Manufacturing & Packaging Facility
Validation & Engineering Consultants
On completion of a review of the current status of the existing validation of equipment, facilities, HVAC and process utilities, The GMP Group (GMPG) was requested to put together a plan for the re-qualification of the complete site. This has entailed the survey and preparation of validation packages for approximately 2000 items of equipment in 400 suited 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 completion and close out of all deviations.
The VMP covered the, DQ, IQ, OQ, & PQ of all new systems and equipment together with the FRS, 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. GMPG was 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.
During the auditing and pre-planning of the project it became clear that there where critical deficiencies in the clients QMS and support systems for the ongoing compliance of the manufacturing and packaging facility. GMPG was able to bring its expertise in areas where the clients skill sets where lacking or in short supply as follows.
- Water Systems
- HVAC and BMS
- Equipment Control & Instrumentation (including PLC control)
- Change Control
- Engineering CAD Services
- Deviation Management
- SAP Input Specialist (Maintenance)
- Electrical Hazard Classification
- Calibration System Redesign and Implementation