Best-in-Class Quality Management System for Quality Performance and Regulatory Compliance End-to-End

Customer satisfaction is at the heart of our quality management system (QMS), which assures products and services of utmost quality. We place the highest priority on product integrity, safe GMP manufacturing, and regulatory compliance (EMA, FDA, ICH). Our best-in-class QMS is founded on state-of-the-art technologies for manufacturing and testing. It is operated by a highly educated and continuously trained team of experts. All materials are sourced from stringently qualified suppliers. Certified quality is assured in every step of the process, from cell line development to scale-up and drug delivery.

Quality Management

ProBioGen’s QMS is based on the standard DIN EN ISO 9001, and is tailored to serve the specific interests of our clients. In addition, ProBioGen holds a manufacturing authorization for GMP-compliant manufacturing and batch-release of biotechnological drug substances. We routinely conduct internal and client audits as well as annual audits by our independent certification company and the respective authority.

Quality risk management paired with an expert management team ensures our high quality standard is met in biopharmaceutical development, manufacturing, and technology transfer. Altogether, our customers’ requirements, applicable legal provisions, and our internal guidelines all constitute our key criteria for these standards. Clients have access to our experts and we support them in regulatory matters.

Quality Certificates

The DQS GmbH (German Society for Quality; the issuing organization) has awarded us the following certificates:

  • Certificate of DIN EN ISO 9001
  • Confirmation of GMP compliance

Manufacturing Authorization

  • Obtained in 2002 according to §13 of the German Medicines Act
  • Competent authority: State Office of Health and Social Affairs Berlin, Germany

Advantages

  • Best-in-class quality assurance, fully certified and audited
  • Access to subject matter experts for QA and regulatory compliance
  • In-house Qualified Person (QP) certifies batches of drug substance for release