Fulfillment of legal requirements
Legal and industry-specific regulations
CSL Behring's biotherapeutics are manufactured in state-of-the-art manufacturing facilities under strict, controlled conditions. Every step of the manufacturing process contributes to the safety of the products. CSL Behring complies with all legal requirements required in the countries in which we manufacture and market our products. In the US, these include the Clinical Laboratory Improvement Act (CLIA) and the Occupational Safety and Health Act (OSHA). In Europe, we meet the requirements of the European Medicines Agency as well as all the requirements of the individual countries in which we operate.
In Germany, the CSL Plasma donation centers are certified by the German Federal Health Office. In addition to the legal requirements, the industry association PPTA (Plasma Protein Therapeutics Association) has introduced additional voluntary standards that guarantee the safe supply of plasma and plasma-derived products. These voluntary standards, which affect both plasma donation and the manufacture of products, go beyond regulatory requirements regarding donation and processing of plasma sources by Fractionating Members. The Quality Standards for Excellence, Quality Assurance and Leadership (QSEAL) certification program applies to fractionators (manufacturers of biotherapies) and provides independent certification of compliance with voluntary standards.
Similarly, the IQPP (International Quality Plasma Program) certification program demonstrates that plasma donation center management meets high quality standards and promotes the safety and quality of enrolled donors and donated plasma. CSL Plasma, CSL Behring's plasma collection division, was one of the first of the QSEAL certified divisions through the PPTA's IQPP program. To achieve and retain certification, each company plasma donation center must meet all QSEAL standards and pass all IQPP inspections. In the United States, CSL Plasma also participates in the National Donor Deferral Registry (NDDR). The NDDR directory was developed by the PPTA and is a nationwide database of plasma donors, who have been permanently excluded from donating plasma. The system also guarantees the safety of plasma and plasma-based products by excluding previously rejected plasma or blood donors. The introduction of a European database of rejected donors is currently being discussed by several European regulatory authorities.
Legal Provisions
CSL Behring complies with all legal requirements required in the countries in which we operate. These include but are not limited to:
• Europe: European Medicines Agency
• Austria: BASG Federal Office for Safety in Health Care
• Germany: German health authority, Paul-Ehrlich-Institut and state offices
• United Kingdom: Medicines and Healthcare Products Regulatory Agency
