Everything is proceeding according to plan – with GEMPEX and the 3C Management® on schedule in new GMP facilities

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The gempex GmbH, GMP service provider from Mannheim, has been supporting Caesar and Loretz GmbH (Caelo) since fall 2014 in the construction of a GMP-compliant building for the primary packaging of active ingredients and pharmaceuticals under non-sterile conditions. Caelo is a leading supplier of pharmaceutical raw materials to pharmacies and hospitals and, in addition to the packaging and delivery of drugs, chemicals, and galenicals, also manufactures ointments, ointment bases, oils, as well as drug and tea blends.

Together with the project manager Drees & Sommer, gempex pursues the goal under the brand 3C-Management® to comprehensively support companies in renovation, extension, and new construction projects in the areas of Construction (building), Commissioning (start-up), and Compliance (quality approval). Building and process planning are closely coordinated, and qualification concepts are established early in the project. This was also the case with Caelo's new construction project in Hilden, where approximately 25 new rooms, corridors, and airlocks were to be built in a GMP-compliant building, modeled after the cleanroom class D.

gempex's task was to handle organizational, coordination, and scheduling management from the perspective of GMP compliance. "We initially expanded the construction schedule at the start of the project to include the necessary GMP topics. This ensures the integrated process of all relevant GMP activities and involves GMP authorities early and purposefully," says Boris Glasbrenner, project manager at gempex GmbH. Furthermore, the requirements for external qualification were jointly defined with Caelo (specification creation). gempex assessed the GMP services offered by external contractors and participated in the awarding discussions. The consistent follow-up of all GMP-relevant documents, including their timely creation during the validation phase, was the responsibility of the GMP expert, as was the support during the authority inspection.

The final authority inspection on April 21 and 22, 2016, by the Düsseldorf District Government was passed without major deviations, allowing Caelo to move into the new premises as early as April 29. Just three days later – on May 2 – Caelo began production under the most modern and safest conditions.

Boris Glasbrenner is very satisfied: "The entire project ran smoothly and absolutely on schedule from the planning phase through construction to acceptance. The collaboration with our partner Drees & Sommer was once again flawless." This is further proof of the success of the 3C-Management® launched in 2013.