The Multidisciplinary Team for the Development of a GMP Production Plant: a holistic view
The comprehensive development of a GMP (Good Manufacturing Practice) production plant is a complex task that requires the collaboration of a highly specialized multidisciplinary team. Each phase of the project requires specific skills and knowledge.
The following is an ideal structure and organization of a theoretical work team, grouped by phases and specialties, specifying the functions of each professional profile.
Teams by development stage
Planning and Development Phase
Product Development and Feasibility Studies Team:
- Pharmacists: In charge of galenic studies and the corresponding development of new pharmaceutical specialties.
- Financial Analysts: Evaluate the profitability of the new specialty, making cost and benefit projections.
- Regulators: They prepare the corresponding registration dossiers and are in charge of dealings with health authorities, ensuring that all procedures comply with current regulations.
- Production technicians: Plan and prepare the pilot batches required for the launch of new specialties.
- CDMO specialists: Coordinate and supervise the production and development of contract drugs for other laboratories or in other facilities outside their own.
Engineering and Design Team:
- Pharmaceutical Process Engineers: Optimize production processes, e.g. to improve their efficiency.
- Production Process Engineers: They are in charge of the necessary machinery, services and technology, such as the implementation of new process systems.
- Architects and Civil Engineers: Design the buildings that will contain the pharmaceutical facilities, considering aspects such as circulation and internal logistics.
- Automation Engineers: Implement automated systems to improve production efficiency and accuracy.
Construction Phase
Technical Project Team:
- Urban planners: Plan the location and distribution of the plant in relation to the environment.
- Architects: They design the structure and aesthetics of the building, considering functional and safety aspects.
- Engineers: Develop HVAC systems, process services, regulation and control systems and critical fluids.
Construction Team:
- Contract Managers: Negotiate and supervise contracts with suppliers and contractors.
- Construction Managers: Supervise the construction, ensuring that the approved design and user requirements as initially defined are followed.
- Licensing Specialists: Manage the necessary permits for the construction and start-up of the plant.
Validation and Certification Phase
Validation Team:
- Cleanroom Specialists: Ensure that critical areas meet cleanliness and asepsis standards.
- Quality Auditors: Perform periodic inspections to ensure compliance with the corresponding regulations applicable to the facility (GMP, GMP…).
- Trainers: Provide courses and training in best practices and specific procedures.
- Calibration Technicians: Ensure that all critical instrumentation is in correct and current calibration.
Teams by development stage
Maintenance Team:
- Preventive Maintenance Technicians: Perform periodic inspections to prevent failures.
- Corrective Maintenance Technicians: Solve specific problems as they arise.
- Technical Assistance Service (TAS): They provide external technical support and assistance in case of problems or failures that cannot be solved by the internal maintenance team.
The development of a GMP production plant is a complex process that requires the collaboration of multiple specialties. With a well-structured and highly qualified team, it is possible to ensure that the plant meets the highest quality and safety standards.
At Global Facilities Group, we understand the importance of customizing the most appropriate team for each project, without oversizing it or forgetting any essential aspect, thus guaranteeing success and efficiency in each phase of the project.
