leading custom projects

The projects are based on achieving a set of defined goals in a concrete amount of time and resources. The key to successfully executing a project is to maintain the equilibrium between three factors; the Quality, cost and time needed to meet the proposed objectives.

At tri-consulting, we take care of meeting our client's objectives according to their needs while maintaining this equilibrium.

Our methodology is defined by a clear objective communication throughout the project with all stakeholders, identify, limit and accurately provide deliverables, act quickly to ensure that any obstacles that could appear do not delay the team and monitor times and costs to balance and to facilitate the flow of activity.

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We can coordinate any type of project due to our extensive experience in highly regulated sectors.

Projects for the improvement and optimization of processes.
Implementation of Quality guidelines.
Projects of new production lines and plants, for both oral and sterile APIs.
Review or audit of designs to detect weak points both regulatorily and ergonomically and the possibility of correctly executing the procedures.

Together with our careful partner selection, we can carry out large-scale turnkey projects, both API production lines or plants, as well as manufacturing facilities for aseptic process projects.

However, if you have trusted companies in charge of different areas of the project, we can provide you with the solutions that you have uncovered, in addition to coordinating the project.

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The actions that we carry out personally within a project of a new production line or new facilities:

URS
The needs of our customers are our priority. Therefore, we help to capture your requirements and complement them with our experience.
Design consultancy
We take care that the design adapts to your needs, to the applicable regulations and that it allows the users to perform the necessary functions in a safe and ergonomic way.
Monitoring and coordination
Coordination of the construction phases and the qualifications of equipment and facilities, taking into account Quality, cost and time.

Design, drafting of SOPs and training of the operators
We write the SOPs according to your facilities and processes. We carry out the necessary training to your operators, both in the SOPs and in the correct behavior practices to comply with the GMPs.
Support in the design and execution of the commissioning
We design the commissioning to enable a smooth and effective transition and we take care of supervising it to solve the incidents that may arise and facilitate it as much as possible.

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In an aseptic process manufacturing project:

Design and review of:
- Autoclave cycles.
- Peroxidation cycles.
- CIP cycles.
- SIP cycles.
- Environmental monitoring system. Design of viable and non-viable particle controls to be carried out within your clean rooms.
Design of the validation of the aseptic process.
Design, drafting of SOPs and training of operators.
We write the SOPs according to your facilities and processes. We carry out the necessary training to your operators, both in the SOPs and in the correct behavior practices to comply with the GMPs.

Support in the design and execution of the commissioning.
We design the commissioning to enable a smooth and affective transition and we take care of supervising it to solve the incidents that may arise and speed it up as much as possible.
Preparation of health authority's audits.
We carry out a previous audit, we propose an action plan of the improvements to be made and we can also train your entire staff to face a health authorities audit with the maximum guarantees.
Data integrity.
We can monitor that the information chain is robust and meets the expectations of regulators and training users on how to maintain proper data integrity and make them aware of the great importance of maintaining it.

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