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Auftritt

Quality Culture

The cornerstone of our competitive advantage lies in the safety and efficacy of our products, which epitomizes our commitment to overall quality. Our rigorous quality assurance journey commences within our research laboratories and extends through meticulous market surveillance measures. This steadfast integration of quality underscores our unwavering commitment to delivering excellence and ensuring the well-being of those we serve

Auftritt diligently oversee our suppliers' procedures to guarantee the utilization of the highest quality materials in our products. Following regulatory approval and the commencement of routine manufacturing, we uphold stringent quality standards throughout the entire process, encompassing both drug substances and drug products.

This unwavering commitment to quality assurance ensures that our products consistently meet the highest standards of safety, efficacy, and reliability, thereby fostering trust and confidence among patients and healthcare professionals alike.

Quality Throughout

At Auftritt, quality is evident throughout every stage of the product lifecycle. Quality oversight starts at the testing facilities, where thorough documentation and proper conduct of non-clinical safety studies are maintained. This ensures adherence to current Good Laboratory Practice (GLP) standards, safeguarding the integrity of the data generated. The focus on quality continues through clinical trials, production, distribution, and concludes with shelf-life monitoring.

Quality During Clinical Stages

During clinical stage development, quality oversight ensures the continuous application of Good Manufacturing Practices (GMPs). Quality is embedded throughout the clinical development process to protect:

  • The safety and rights of our study participants
  • The accuracy and reliability of data submitted to health authorities
  • Full compliance with all current Good Clinical Practices (GCPs)

Our clinical Quality Management System includes comprehensive oversight of clinical research documents, activities, and information management systems. Furthermore, Auftritt emphasizes quality not only within our own operations but also in the processes of our vendors, investigators, and contractors who collaborate with us during the clinical phase.

Quality throughout the manufacturing process

Auftritt is equipped with cutting-edge manufacturing facilities and employs the most advanced testing equipment to ensure the highest quality standards for our products. We also closely monitor the procedures of our suppliers to guarantee that only premium materials are used in our products.

After regulatory approval, as a product enters routine manufacturing, we maintain strict quality control throughout the entire process, ensuring consistent quality for both drug substances and drug products.

Quality During production

The manufacturing processes at Auftritt are meticulously validated, ensuring that each step is carried out with precision. All equipment undergoes rigorous testing and certification to confirm its reliability and efficiency. Additionally, the test methods employed are carefully verified and standardized, guaranteeing that each product consistently meets the highest quality standards with reproducible results.

To foster ongoing excellence, Auftritt follows a culture of continuous improvement, regularly reviewing and refining processes and procedures. This commitment to innovation ensures that all operations remain up-to-date with the latest advancements, further enhancing product quality, operational efficiency, and regulatory compliance.

Certified Excellence