Evonik is one of the world leaders in specialty chemicals. The company is active in more than 100 countries around the world and generated sales of € 15.2 billion in 2024. The group’s Health Care business line is a global innovation hub for the companies from the pharmaceutical and medical device industries, supporting customers along the entire product cycle.
Evonik planned the construction of a new spray drying plant for EUDRAGIT® dispersions, including a new building at the Darmstadt site. The GMP concepts established at the site and in the business line apply here.
gempex supports Evonik Operations GmbH | Health Care.
Consulting and conceptual support for the implementation of GMP requirements were required to accompany the conceptual and detail engineering. This included a higher-level user requirement specification, a project master plan, the documentation for the qualification stages DQ, IQ and OQ for the production plant, the clean room area and the media supply. In addition, GMP project management and support for overall project coordination until all qualification stages were provided. During detail engineering close coordination with the plant supplier was requested.
Initially, a user requirement specification was worked out in cooperation with the customer while the conceptual engineering was caried out.
With the beginning of the detail engineering, a GMP project master plan was created that defined the concept, approach and templates. Thereby, the project was implemented in the higher-level site quality system.
After internal approval, the detailed GMP planning was developed using risk assessment. The results of existing risk assessments were incorporated. Integrated into the commissioning phase, the qualification activities DQ, IQ and OQ were carried out using supplier documentation. The necessary documents were worked out in cooperation with the customer's quality unit.
The new production plant for spray drying of aqueous dispersions was successfully put into operation. All GMP requirements were implemented reliably and smoothly thanks to constant support from concept engineering to the completion of qualification.
Key Performances of gempex were:
- GMP user requirement specification
- GMP risk assessments
- Detail engineering support
- Qualification master planning
- Qualification DQ, IQ, OQ
- Project support
For any questions on the topic Qualification in new construction, Ralf Gengenbach, Managing Director of gempex GmbH, will be happy to be contacted via contact@gempex.com.
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