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The client, an international pharmaceutical company, was launching a new manufacturing site for sterile drug production. Within the project scope, it was necessary to provide comprehensive support during the commissioning phase — from verifying the performance of engineering systems to preparing documentation in compliance with international GMP and FDA standards.
The main challenge was the tight timeline to transition from the construction phase to production, while meeting stringent quality and safety requirements.
Our team developed a step-by-step commissioning strategy that included:
Special attention was given to communication between equipment suppliers, the client’s technical department, and regulatory consultants. This ensured that delays were avoided and identified deviations were resolved quickly.
As a result, commissioning was successfully completed, and the manufacturing site was fully prepared for validation and subsequent production. The transition time from the construction stage to the first production cycle was reduced by 20% compared to the initial schedule.
All engineering systems passed verification without critical deviations, and the documentation was approved by the client’s internal quality department. Thanks to a structured approach and close collaboration with all stakeholders, the client gained full confidence in the site’s readiness for GMP and FDA audits.
From formulation to full-scale production, we transforms specifications into certified, high-performance outcomes!
