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Quality Management

Quality Management

ProBioGen’s quality management system is based on the standard DIN EN ISO 9001:2008, and is specifically tailored to serve the client's interests. In addition to these quality certificates ProBioGen holds a manufacturing authorization for GMP compliant manufacturing and batch release of biotechnological drug substances. 

In order to guarantee this high standard consistently, we routinely conduct internal audits, undergo client audit, and those from the competent authority.

The resulting high quality level of ProBioGen’s products is the sum of the qualities of all individual process steps involved in their production. Consequently, an outstanding product can only be created through excellent development, optimization and manufacturing processes. The tools we use to ensure quality in biopharmaceutical development, manufacturing and technology transfer are knowledge management and quality risk management. Altogether, our customers’ requirements, any applicable legal specifications and guidelines, and our own standards constitute the key criteria which we apply in actively defining our ProBioGen quality standards. We make our experience available to clients and provide regulatory support (both formally and by substantive work) for the marketing authorization, in particular relating to biopharmaceuticals scientific advice and the Investigational Medicinal Product Dossier (IMPD/IND).

A major goal of our quality policy is establishing long-term relationships with our clients, which is built on lasting mutual trust. For this reason, customer satisfaction is our prime key performance indicator.

Quality Certificates

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

  • Certificate of DIN EN ISO 9001:2008
  • Confirmation of GMP compliance

Manufacturing Authorization

Manufacturing of biological drug substances is licensed by the competent authority, according to §13 of the German Medicines Act.

  • Number of the Manufacturing Authorization: 5373/1-ProBioGen/2
  • Registration scope: Drug Substances from Mammalian Cell Lines for Clinical Trails
  • Valid since: June 10, 2005
  • Competent authority: State Office of Health and Social Affairs Berlin, Germany

Batch Release

In line with EU GMP requirements, the designated Qualified Person (QP) at ProBioGen provides either full or partial certification steps for Investigational Medicinal Products for use within the European Union.

Relevant Guidelines

Below is a non-exhaustive list of relevant guidelines which are applicable for typical biotechnological projects:

  • German Medicines Act (affected by guidelines 2001/83/EC and 2003/63/EC)
  • Regulation for the manufacturing of drug products and drug substances (affected by 2003/94/EC)
  • ICH Q7: EU GMP Guideline Part II and relevant annexes 2, 13 and 16
  • ICH Q5A to D
  • ICH Q6B
  • ICH Q8, Q9, Q10
  • TSE Guidelines
  • Guideline on development, production, characterization, and specifications for monoclonal antibodies and related products (December 2008)
  • Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (February 1997)
  • Guidance for Industry – cGMP for Phase 1 Investigational Drugs (July 2008)