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Quality System

Microsynth AG is certified to ISO 9001:2015 and accredited according to ISO/IEC 17025:2017 (STS 0429) for Sanger sequencing, next generation sequencing and fragment length analysis. Microsynth's oligonucleotide synthesis facility is EN ISO 13485:2016 certified, which means we are certified for the production and distribution of nucleic acids and components for IVD manufacturers and provision of associated activities. The company participates in proficiency tests. Proficiency tests are an important part of on-going qualification/validation.
Our Sanger sequencing laboratory holds the GMP Compliance issued by Swissmedic for manufacturing medical products including quality control (chemical, physical, biochemical and biological) of medical products as a contract laboratory.
The Qualified Person (QP) is in direct contact with relevant production coordinators on GxP issues and cooperates with production to ensure continuous improvement. The QP provides details on corrective actions required for batch deviations and assists in the implementation of quality systems within production to ensure compliance with GxP.
In addition, we are working according to the EU Guidelines for Good Manufacturing Practice (EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines / Arzneimittel-Bewilligungsverordnung (AMBV) and the ICH / PIC/S Guidance in GxP-projects (Contract Research)).
Company structure in terms of processes, interfaces and responsibility of resources are described in the Quality Manual. Process performance is monitored via Key Performance Indicators (KPI) and continuously improved via quality objectives and continuous improvement (KV). QMS relevant documentation and the associated records are managed in a controlled manner. This includes approval and release, identification, creation date and versioning. Change management, a continuous improvement process and risk management are implemented. Non-conformities / OOS are linked to a CAPA process. Customer complaints and deviations are recorded and brought into team meetings for training.
Processes are described in procedures and SOPs. They are reviewed periodically. We maintain a clean and hygienic manufacturing area. The processes are clearly defined, validated and controlled. Instruments are qualified. The requalification period is defined. Instrument-related test documents are archived. Changes that affect the quality are validated if necessary. In cases where the quality cannot be covered by verification, the production process is validated. Records demonstrate that all the steps required by the defined procedures and instructions are in fact taken. Deviations are investigated and documented. Records of manufacture that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
Operators are trained regularly in practical work and documentation procedures. New personnel are trained according to an introductory plan. This is documented in a dedicated dossier. If new functions are taken over, the pre-defined training/introduction must be attended.
Audits are performed to confirm that activities within the different processes correspond to internal and external demands, as well as to investigate the efficiency and suitability of the quality management system. By internal audits it is verified that the company policy is implemented throughout the entire organization. Supplier qualification is performed regularly.