The timeline for completing a project varies depending on the size and complexity of the project. We work with our clients to establish realistic timelines and ensure that projects are completed on time. These are the approximate project phases that are essential to the execution:
Project Charter Phase - Projects start with aligning the project and business drivers within the Project Charter. The charter is typically approved by the company's management.
Project Feasibility Study - In this phase the evaluation of project fit to the available facility, equipment, utility/services are performed. Is the project feasible and reflects drivers in the Project Charter. Usually, this phase is supported by the milestone schedule and Order of Magnitude Estimate. The leading option is proposed.
Concept Design and Scope Development Phase - In this phase, the leading option is approved by the management and the scope equipment and associated facilities is determined. Frequently, it will be necessary to have pre-spend funds that will purchase number of Long Lead Equipment. The project cost estimate should be approximately 30% accurate, and the schedule is expended to contain major sub-step activities. After this stage the design is approximately 10% complete.
Basic / Schematic Design Phase - In this phase, the major items of design that requires process details, key specifications, critical facility / utility features are defined. All of the equipment is normally sized and specified. The design is at approximately 30% completion, and the budget is close to 10% accurate. The schedule activities expand to include major details of engineering, construction, commissioning and qualification, and procurement. Typically, the project funding is fully approved to move into the implementation of the project going forward at the end of this phase.
Detailed Design / Construction Documents Phase - In this phase, even the minor aspects of the design are finalized. Certified design drawings are prepared. Pre-construction phase is going forward (with permitting plans, construction execution details, construction safety requirements, sub-contract award plans, etc.). At this stage, the project schedule must be completely integrated, and pre-construction estimate defined.
Construction Execution Phase - This is where facility is constructed in accordance to the integration schedule and budget requirements. This phase may be implemented by the Construction Manager (CM) or a General Contractor (GC) depending on the project complexity and scope. Generally, the purchased Equipment is tested at the vendor and delivered on-site (or 3rd party location) and installed. At the end of this phase the CM/GC typically hand-over the Mechanical Completion of the Equipment / Facilities to the Commissioning. Any queries and issues are resolved with the Engineer of Record.
Commissioning Execution Phase - In this phase, the equipment systems and facility systems are started up by going through a static verification step, and the dynamic start-up steps. This step is absolutely essential to ensure that the design aspects of the project are reflected, and systems operate within safe limits and as intended.
Qualification Execution Phase - In this phase, the critical GMP equipment and facilities (e.g. HVAC, process gases) are validated as required for the pharmaceutical facilities. It is required to conduct the Installation and Operational qualifications of GMP systems, and follow up with the Performance Qualifications where required performance will be assured to be reproducible. Qualifications are typically done through the appropriate protocols.
Validation Execution Phase - At times, it is necessary to validate specific requirements for process, cleaning, and environmental monitoring to ensure that the equipment and facility is validated to deliver on the critical aspects and meet critical process parameters. After this phase, the Equipment / Process and Facility are turned over to the Stakeholders and released for the GMP use.
Project Close Out Phase - This phase is to ensure that all project required documentation, deliverables are closed out and turned-over to the clients within reasonable time.