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Quality Control

The Octapharma Quality Control System comprises:

 

  • In-process tests
    Group-wide, identical, in-process test plans based on extensive risk assessments ensure that all processes are controlled in a standardised manner. This approach guarantees the manufacture of consistently high-quality protein products and medicines.
  • Final product testing
    As demanded by relevant pharmacopoeias (national published references detailing guidelines for sample identification and medicine preparation), every batch of final medicinal product is tested for compliance with its product specification. This is the basis of the Marketing Authorization granted from national Ministries of Health, and also a prerequisite for the release of a batch of medicinal product for human use.
  • Batch release
    When a final product batch has successfully passed all manufacturing steps and quality controls, the complete documentation undergoes a final assessment by the Release Officer. Analytical test results and biological safety data must comply with the specified standards, and packaging must be in line with the requirements of the marketing license in the country where the product is destined to be used. In the European Community, responsible health authorities perform parallel testing of key parameters and virological safety markers and issue an Official Control Authority Batch Release to the manufacturer. Finally, if all these preconditions are fulfilled, the batch is certified and released for shipment by the Qualified Person in charge.
  • Microbiological tests
    An extensive program for environmental monitoring guarantees that all Octapharma premises, equipment, personnel and process media are certified for aseptic processing.
    In-process monitoring of the microbial load, microbiological monitoring of the aseptic filling process, and sterility testing of the final medicinal product guarantee that only proven sterile products are released for treatment of patients.
  • Stability studies
    State-of-the-art stability studies are performed on all newly developed products and on every change in the production process to verify and trace the stability of Octapharma products throughout their life cycle. This Group-wide program includes the ongoing (annual batch program) stability program as required by leading regulatory bodies in the US and in Europe.
  • Standardised test methods
    In extensive studies prior to implementation of new tests, performance characteristics are verified and submitted for approval to competent authorities all over the world. This program includes physical, chemical, biochemical and (micro) biological tests. All test methods are performed on Octapharma’s standardised equipment, which guarantees that all hardware and reagents used in Octapharma operations worldwide are identical. All key test-parameters are regularly compared to ensure long-term consistency between all Octapharma sites. To ensure harmonisation between Octapharma and global regulatory authorities, laboratory personnel attend internationally acknowledged inter-comparison programs, and contribute to internationally conducted collaborative studies for establishing new standards. These global authorities include WHO (World Health Organisation), FDA (Food and Drug Administration), EDQM (European Directorate for the Quality of Medicines and Healthcare), and NIBSC (National Institute for Biological Standards and Control).
  • High-quality raw materials
    All raw materials are specified according to all relevant international pharmacopoeias, such as those from the United States (USP), Europe (Ph.Eur.) or Japan (JP). Raw materials are procured from selected suppliers which undergo the extensive Octapharma Supplier Qualification Program. Upon receipt of a raw material batch, the quality of every single container is verified prior to release for manufacturing processes.