Similasan AG develops and manufactures homeopathic medicines. The company, based in Jonen in the canton of Aargau, employs around 100 people in Switzerland. Its product range includes more than 110 homeopathic preparations approved by Swissmedic. Similasan is the world's largest manufacturer of natural eye drops.
gempex supports Similasan AG.
The existing sterile filling line for eye drops, the bulk production clean room area, and the WFI system needed to be adapted to the requirements of the new Annex 1. The challenges included the remediation of the existing plant during parallel running production, upgrading the QM system, flexible resource reinforcement, and passing the related inspections.
Overall project management for all sub-projects was required as well as comprehensive consulting and intensive active support for all necessary accompanying qualification measures – from URS to PQ. Support was provided for the technical design of the filling line conversion. After replacement, the WFI system had to be brought through phases PQ I-III.
Furthermore, the planning and execution of the validations, including the aseptic process simulation, had to be supported. The entire QMS had to be adapted to the new situation. QA tasks were taken on as a temporarily outsourced service. Together with the customer, the inspections had to be prepared, witnessed and followed up. Commissioning support completed the package of tasks.
In close coordination with the customer, support was provided primarily on site with a team of up to four people, supported by additional subject matter experts, for example in the field of IT validation. A temporary deputy QA manager was installed. An experienced consultant led the project and was available at all times to answer any critical questions.
After an intensive upgrade, the old aseptic filling line was successfully adapted to the high requirements of the new EU GMP Annex 1 guideline, the inspections were passed. Future-proof, Similasan AG can now manufacture and distribute eye drops in accordance with the latest and highest quality standards.
Key Performances of gempex in this project were:
- GMP upgrade
- EU GMP Annex 1 Consulting
- Project Management
- URS, SMF
- Qualification, Validation, SOPs
- QMS upgrade and QA support
- Construction, design
- CSV according to GAMP
- Swissmedic inspection support and assistance
For any questions on the topic Consulting Annex 1 Implementation or GMP-Upgrade, Ralf Gengenbach, Managing Director of gempex GmbH, will be happy to be contacted via contact@gempex.com.
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