Everything Goes According to Plan – With gempex and the 3C-Management® on Schedule in to New GMP Facilities

Everything Goes According to Plan – With gempex and the 3C-Management® on Schedule in to New GMP Facilities

gempex GmbH, the GMP service provider from Mannheim, has been assisting Caesar and Loretz GmbH (Caelo) in the construction of a GMP building for the primary manufacturing of active ingredients and medicinal products under non-sterile conditions since the autumn of 2014. Caelo is a leading supplier of pharmaceutical raw materials to pharmacies and hospitals and, in addition to the manufacturing and supply of drugs, chemicals and galenicals, it also manufactures ointments, ointment bases, oils, drugs and herbal teas in house.

Together with project managers Drees & Sommer, gempex pursues the objective of providing companies with an integrated service in conversions, extensions and new construction work in the fields of construction, commissioning and compliance (quality acceptance) in terms of the 3C Management® brand. Building and process planning are closely coordinated and training concepts are already established right at the start of the project. This also applies to the new construction project of Caelo in Hilden, where about 25 new rooms, corridors and passages should be built in a GMP-compliant building based on the class D cleanroom.

gempex’s task was to take over the organisation, coordination and time management from the GMP-compliance perspective. “We have extended the construction schedule right from the start of the project to include the necessary GMP topics”, said Boris Glasbrenner, Project Manager at gempex GmbH. “This ensures the integrated progression of all the relevant GMP activities and purposely integrate the GMP authorities early on.” In addition, the requirements for external qualification were established jointly with Caelo (performance specifications). gempex rated the GMP performances of external systems and participated in the awarding discussions. The consistent tracking of all GMP-relevant documents, including their timely creation within the validation phase was incumbent on the GMP experts as was the support at the meeting with the authorities.

The final appointment with the authorities of the Dusseldorf district government on 21 and 22 April 2016 was passed without any major deviations, so Caelo could begin to move into the new premises on 29 April. Only three days later – on 2 May – Caelo started with production under the most modern and safest conditions.

Boris Glasbrenner is very satisfied: “The whole project ran smoothly and absolutely on schedule right from the start of the design phase through construction to acceptance. The cooperation with our partners Drees & Sommer once again was immaculate.” Another testimonial to the success of 3C Management® launched in 2013.