Not every project undertaken in a manufacturing facility is a good manufacturing project. Those that are, however, can utilize a five-step approach to support an effective and efficient implementation. The benefits of such an approach will ensure that no elements of the project slip through the cracks. Furthermore, the five-phase approach will help the GMP project stay on schedule and within budget. Taken from a Jorge Cordero presentation at IVT’s Validation Week Canada, the following are the tasks and responsibilities associated with each phase.
1. Project Origination
The first aspect of this phase is identifying the project. The project will be identified by the process owner, quality assurance group, or process excellence team based on the business or regulation needs. This will require a project proposal. The project will be evaluated by the process excellence team with an evaluation-rating matrix and will ultimately be selected by upper management. This phase is applicable to all projects.
2. Project Initiation
Like any project, a team needs to be developed by a project manager. In this phase, the project definition will be established by the project manager, project engineer, process owner, quality assurance, and procurement. The initial risk identification (high, medium, low) will occur during this phase. The project plan will be developed by the project manager, and it will be approved by the project team members. In this phase, the project should have an established charter, schedule, user requirement specification, and budget estimate. Impact assessments should be commenced to determine whether the project is GMP or non-GMP.
3. Project Planning and Design
All team members should participate in project meetings and expectations during this phase. The project definition will be redefined during this phase. This includes changes to:
- The scope; a responsibility of the process engineer and process owner.
- The schedule; a responsibility of the project manager and process engineer
- Quality standards; a responsibility of quality assurance.
- Budget; a responsibility project manager, process engineer, and procurement.
The project plan will then be approved. The vendor, if applicable, will be selected by the process engineer and procurement. Finally, the design will be verified and approved by the process engineer, process owner, and quality assurance. Functional risk assessments, traceability matrices, and validation strategies will be used during this phase.
4. Project Execution and Control
The development of the equipment, control system, software, process or facility (ECS-SPF) will be verified by the process engineer, process owner, and quality assurance. Installation and operation verification will be performed by the process engineer and quality assurance. The project manager and the process owner will implement calibration, procedures, and preventative maintenance. They will update and/or create standard operational procedure and preventive maintenance task, and include any critical instrumentation to the calibration process. Factory acceptance tests (FAT), site acceptance tests (SAT), engineering studies, risk assessment reviews, qualification/validation protocols, and SOP, preventative maintenance, and calibration programs will be used during this phase. As recommended by the validation strategy, FAT and SAT should cover all details, configurations, functionalities, and safety requirements. Then, limited IQ, OQ, and PQ can be performed on the basis of successful FAT and SAT.
5. Project Close-Out
The project close-out will require the project manager and project engineer to execute implementation verification. A traceability matrix will be used to verify that all critical requirements in user requirement specifications, functional requirement specification, and design specification, as applicable, were tested in one of the deliverables. Risk assessment review will be performed by process excellence, the process owner, and quality assurance to assure risk was mitigating and controlled. A close-out letter, summarizing the activities performance and completion, should be written by the project manager.
When each phase has been completed, a formal phase review report should be evaluated and approved by the project team members. All of the tasks should be completed before moving on to the next phase; if any task was not completed, a justification should be provided on the phase review report. Throughout the project, there should be consistent meetings of the project team. The project manager and project engineer should report and maintain the visibility of the project.
How to Measure Success
Numerous variables can measure the success of a GMP project. One is whether the user requirements, functional requirements, and design specifications were addressed and tested satisfactorily on FAT, SAT, IQ/OQ/PQ, or process validation. Furthermore, if the IQ/OQ/PQ and process validation have been executed satisfactorily and approved. And of course, if the project has been implemented and closed on time within budget!