Pharmaceutical & Life Sciences
Pharmaceutical projects - with the global requirement in medicine in both animal & human health the Pharmaceutical sector is an environment with fast pace projects, and very stringent schedule & budget requirements.
The most important aspect any pharmaceutical project is understanding the current demand and supply of medicines/ vaccines and being able to adapt the process, structure to meet these requirements.
As any project there will be an identified process owner, quality assurance group, or process excellence team based on the business or regulation needs to provide support to ensure that the stringent compliance & regulatory process is followed.
Prior to the initiation of this project 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.
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.
The development of the key equipment, control system, software, process or facility 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.
Our experienced project managers can support the process owner to establish procedures and develop protocols to update and/or create standard operational procedure and preventive maintenance task and include any critical instrumentation to the modification or replacement process.
Procedures such as 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 to ensure processes are monitored and validated for GMP standards.
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 we provide the support to the owner even at PQ stage if required through validation of documents.
With the above processes in pharmaceutical projects our services can be quite diverse. The sectors and stages from Concept through to BOD and eventually into IQ/OQ and then into the PQ phases.
We can provide the full life cycle support in project controls, project management & procurement. We are also able to provide C& Q expertise if this is required.
We provide these services to clients who are involved in the following projects: Pharmaceutical Refurbishment projects, maintenance or greenfield projects which include new vaccine lines, packaging facilities, cold stores & construction of laboratories.
Our drive is the implementation of portfolio cost reporting over multiple projects and locations through all phases of the projects. Focusing on benchmarking and historical data to support financial control of assets.