| |
GMP SERVICES
Applying international standards and recommendations, INGECLIMA collaborates to establish a validation master plan, based on a risk analysis, which allows for classification of the facilities, systems and components according to their criticality and their impact on the final product.
Based on this detailed study, the facilities are designed and the components selected.
In this way, INGECLIMA accompanies the client from the project's initial stage until its validation and final delivery to the user.
We have developed—as a tool—a perfectly documented Commissioning and Qualification Plan, which allows us to ensure the product's final quality. Its main phases are:
• Risk analysis.
• Design Qualification (D.Q.).
• Factory Acceptance Test and Site Acceptance Test (FAT/SAT).
• Installation Qualification (IQ).
• Commissioning.
• Operational qualification (O.Q.).
|
