The development of a project in the pharmaceutical industry requires a planning meticulous, coordination Multidisciplinary and compliance of normative International Understand the life cycle of a pharmaceutical project allows better manage resources, anticipate risks and guarantee results of quality, insurance and efficient.
Next, the critical stages that make up the technical life cycle of a pharmaceutical project are described, structured to ensure execution in accordance with functional requirements, Operations and normative established by regulatory authorities and good engineering practices (GP).
1. Viability evaluation and scope definition
This stage defines the technical and economic foundations of the project. The Regulatory requirements applicable (GMP, FDA, EMA), functional objectives and of productive capacity, and the User Requirements (USE).
The viability analysis includes impact studies, preliminary technical risks and cost-benefit analysis. This input will be the basis for the entire subsequent design.
2. Conceptual and basic design
Here an initial technical scheme is elaborated based on the USsses. The ones are defined Materials flows, personal and residuity, he layout general, the zoning by environmental classification and the critical services needs such as HVAC, PW, WFI, pure steam, Black Utilities and Technical Gases. In addition, the health design criteria and the preliminary strategy of quality and compliance control are established. This phase allows to validate the engineering principles before advancing.
3. Detailed design and planning
The detail engineering: Constructive plans, P&D diagrams, equipment lists, technical specifications, and dimensioning of profits. Likewise, the Project schedule, he budget definitive, the Responsibilities Matrix and the Validation Master Plan. This stage allows to ensure coherence between requirements, technical solutions and deadlines.
4. Construction and assembly
It includes the physical execution of the project according to the approved design: civil works, installation of HVAC systems, clean utilities networks, wiring, assembly of equipment and control connections. It is essential to ensure Material traceability, apply Quality inspections on site and coordinate interfaces between disciplines. Security and document management must be active from day one.
5. Qualification and validation
This phase guarantees that critical systems operate according to the defined requirements. The phases of IQ (Installation qualification), OQ (Qualification of the operation) and PQ (Performance qualification). The documentation generated must Comply with regulatory standards as GMP and ensure the traceability, integrity of data and reproducibility of the process. The entire system must be validated before commercial use.
6. Commissioning and transfer
During this stage the final operability tests, parameter settings and staff technical training. The TECNICOS files, Calibration certificates, Operation manuals and maintenance. The formal transfer implies internal audits and final validations that certify that the plant is ready for production under regulatory standards.
7. Operation and Maintenance
The productive phase under validated conditions. Preventive maintenance systems, periodic calibrations, online controls and deviation management are activated. Revalidations are made according to defined cycles and any change is documented through the change control. Continuous improvement based on technical indicators ensures the long -term stability of the system.
Understand and correctly apply each phase of the technical life cycle of a pharmaceutical project allows guarantee robust, validated and ready facilities to operate according to the most demanding standards in the sector. In IDI, we accompany our clients at each stage, from conceptual design to the operation, providing regulatory experience, qualification and validation methodologies, in addition to results -oriented engineering solutions.
Are you planning your next project? Contact us and discover how we can help you come true with the maximum technical and normative guarantee.