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Quality System

Microsynth AG is certified according 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 certified according to EN ISO 13485:2016, which is formal recognition of our competencies in the area of production and distribution of nucleic acids and components for IVD manufacturers and the provision of associated activities. The company participates in proficiency tests, which are an important part of on-going qualification/validation.
Our Sanger sequencing laboratory holds the GMP Compliance certification 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 in all our processes. 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)).
Our company structure in terms of processes, interfaces, and responsibility of resources is described in the Quality Manual. Process performance is monitored via Key Performance Indicators (KPIs) and it is enhanced 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, which is 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 up at team meetings so that they can be incorporated into our training programs.
Processes are described in Standard Operating Procedures (SOPs) and they are reviewed periodically. We always maintain a clean and hygienic manufacturing area and our processes are clearly defined, validated, and controlled. Furthermore, instruments are qualified and the requalification period is defined. Instrument-related test documents are archived, and 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 have in fact been taken. Any 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.
Our operators receive training on a regular basis in practical work and documentation procedures. In addition, all new personnel are trained according to a clearly defined introductory plan, which is documented in a dedicated dossier. If new functions are taken over by our employees, the pre-defined training/introduction must be completed.
Audits are performed not only to confirm that activities within the different processes correspond to internal and external demands but also, to investigate the efficiency and suitability of the quality management system. By conducting internal audits we are able to verify that the company policy is being implemented throughout the entire organization. Furthermore, supplier qualification is performed on a regular basis.