Our expertise
SYNEXIN brings together several specialised entities and does not simply supply the equipment, furniture or consumables your project requires — it supports you throughout its execution with a comprehensive approach: from implementation to completion, including the qualification of your equipment and critical environments through dedicated technical follow-up.​
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360° solutions for critical environments
SYNEXIN brings together several entities specialised in clean and sterile processes, airflow expertise, the design and fitting of critical areas, and cleanroom consumables. Whatever your project or challenge in a clean or sterile environment, we provide 360° solutions aligned with pharmaceutical regulatory frameworks. Trust us — we take care of everything.
The single point of contact for the engineering of your clean and sterile processes: process equipment, technical services, consumables and personnel protective equipment.
The specialist in controlled environments: equipment and components for airflow systems, qualification of critical environments and equipment.
The expert in the design and integration of custom-made furniture for cleanrooms: inspection tables, specialist furniture, changing rooms, airlocks, benches and sinks.
Our synergy at your service
Our in-house engineering department draws on the extensive expertise that the Group's entities have built up over the years. SYNEXIN Engineering consolidates and centralises this know-how to address all of your critical environment projects.
Building on this expertise and wide-ranging capabilities, SYNEXIN is well-positioned to propose and establish a validation strategy for your project, based on process risk analyses and design qualifications.
Conceptual study
- Identify requirements
- Audit and diagnose
- Verify and validate feasibility
- Analyse risks
Detailed pre-project planning
- Allocate resources
- Define stakeholders
- Define objectives and technical specifications
- Build the schedule and define key milestones
Execution & project management
- Launch into production
- Coordinate and manage project teams
- Analyse performance indicators
- Control risks
- Validate processes at each key milestone
Qualification & validation
- Establish documentation
- Deliver the project
- Qualify processes
- Validate the achievement of objectives
Production start-up
- Train the personnel involved
- Implement standard operating procedures
- Capitalise on experience gained
Support & follow-up
- Maintain collaboration through a dedicated customer service
- Continuously optimise and improve
- Upskill personnel through training programmes
Validation Master Plan
The Validation Master Plan identifies the strategies and tools to be used to carry out and control the commissioning and qualification activities required to ensure the full handover of installations to the operators.
In accordance with Annex 15 of the GMP guidelines, the Validation Master Plan or equivalent document must define the qualification/validation system and include or reference at minimum the following elements:
- Qualification and validation policy
- Reference standards and regulations
- Organisational structure, including roles and responsibilities for qualification and validation activities
- Summary of the site's facilities, equipment, systems and processes, and their qualification and validation status
- Change control and deviation management as applied to qualification and validation
- Recommendations for the determination of acceptance criteria
- References to existing documents
- Qualification and validation strategy, including re-qualification where applicable
It also serves to:
- Specify the boundaries or scope of responsibilities between the client and the supplier
- Specify a macro-level schedule for the validation strategy
- Control the handover of installations (from suppliers to client and from the project to the operators)
Risk analysis
Process risk analysis is an essential step in project management. It involves:
- Compiling an inventory of risks for all stakeholders (maintenance, operators, metrology)
- Assessing risks through a risk scoring system based on severity, calculated from occurrence, frequency and detectability
- Defining appropriate mitigation measures and tests based on risk scores in order to reduce their occurrence
All of these steps are aimed at identifying the critical elements that will necessarily be integrated into the qualification protocols. We provide a comprehensive dossier comprising:
- A summary of each function of your system
- A summary of the risks associated with each function
- Identification of the causes and consequences of each risk, along with their criticality
- Possible risk control measures
- Development of the validation strategy through the definition of validation tests
This dossier is drawn up in accordance with the following regulatory frameworks:
| Reference​ | Title / Source |
| GMP revised 26/11/2020 | Good Manufacturing Practices |
| EU GMP – Annex 1, 22/08/2022 | Manufacture of Sterile Medicinal Products |
| GMP – Annex 11 | Computerised Systems |
| GMP – Annex 15 | Qualification and Validation |
| ISO 9001 rev. 2015 | Quality Management Systems Standard |
| ICH Q9 | ICH Harmonised Tripartite Guideline — Quality Risk Management |
| ISPE Baseline Guide Vol. 5 | ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities, Vol. 5 — Commissioning and Qualification |
| ISPE Baseline Guide Vol. 12 (GAMP 5) | Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment |
Design qualification
The design qualification is the document in which the conformity of the design with the required regulatory frameworks must be demonstrated and documented. The requirements set out in the user requirement specifications must also be verified during the design qualification.
We provide a document that addresses point by point the requirements of your technical specifications as well as those of the GMP guidelines relating to your system, in which each conformity is noted and justified by reference to the supplier's documentation.
This document therefore serves to highlight points of attention, risk or deviation prior to execution.
