Certification for the Manufacturing of Excipients According to EXCiPACT - on the way to GMP for active ingredients manufacturing for clinical investigational medicinal products

metabion GmbH is a biotechnology company headquartered in Munich, Germany. Founded in 1997, metabion has achieved a worldwide leadership position in the custom nucleic acid synthesis market segment. As a global player in the niche market of custom oligonucleotides, the company delivers to more than 80 countries. The company's mission is to drive and support scientific progress and translate it into diagnostic and therapeutic solutions.

gempex supports metabion GmbH.

metabion is working on establishing GMP-certified active ingredient manufacturing for investigational medicinal products at its new site in Munich-Kirchheim. The first milestone for this was the EXCiPACT certification for the manufacturing of excipients, incorporating GMP regulations. 

The processes, plants, systems, and quality management for the new production of investigational medicinal products had to be designed to meet the requirements of ECXiPACT and implemented in an inspection-safe manner with a view to subsequent GMP certification. Full service as required, from design review to inspection support. 

Based on a gap analysis, a concept for the upgrade of the QMS was developed. Measures included employee training and education, software validation, risk analyses, preparation of SOPs, and support for qualification and validation of the relevant plants and processes. 

SOPs, process flow and cleanroom plans were developed and finalized in workshops. The design review of the new construction led to the joint development of a project URS for the new site in Kirchheim. GMP-relevant aspects were identified, consultancy was provided on their planning, and contacts with the local supervisory authority were supported. 

In preparation for the inspection, an internal mock audit was carried out and the last weak points were eliminated. Support during the actual EXCiPACT inspection ensured a successful procedure. 

The EXCiPACT certification was passed very successfully without any findings. The report highlights very reliable processes and highest hygiene standards.

For questions on the subject of qualitymanagement systems, Frank Studt, Managing Director gempex GmbH, is available via contact@gempex.com.