Compliance with Regulatory Requirements
Government & Industry Regulations
CSL Behring biotherapies are manufactured in state-of-the-art facilities under stringent, controlled conditions. Each step of the manufacturing process contributes to the safety of the products. CSL Behring also complies with all government regulations set forth by the countries in which we manufacture and market products. In the US, this includes the Food and Drug Administration, Clinical Laboratory Improvement Act (CLIA) and Occupational Safety and Health Act (OSHA). In Europe, we adhere to requirements established by the European Medicines Agency as well as requirements specified by each of the individual countries in which we operate. In Germany, CSL Plasma centers are certified by the German Health Authority (GHA).
In addition to governmental regulations, the Plasma Protein Therapeutics Association (PPTA), the industry trade association, has established additional voluntary standards to ensure a safe supply of plasma and plasma-derived products. These voluntary standards, which apply both to plasma collection and product manufacturing, exceed the regulatory requirements associated with collecting, processing and testing of Source Plasma by member fractionators.
The Quality Standards of Excellence, Assurance and Leadership (QSEAL) certification program applies to fractionators (manufacturers of biotherapies) and provides independent certification of adherence to the voluntary standards. Similarly, the
International Quality Plasma Program (IQPP) certification program demonstrates that a plasma collection center provides a high-quality business operation that promotes the safety and quality of committed donors and donated plasma.
CSL Plasma, CSL Behring’s plasma collection division, was among the first in the industry to be QSEAL-certified through PPTA’s IQPP program. To become and remain certified, each of the company’s plasma collection centers must meet all QSEAL standards and pass all IQPP inspections.
In the US, CSL Plasma also participates in the National Donor Deferral Registry (NDDR). Developed by the PPTA, the NDDR registry is a nationwide database of plasma donors who have been permanently deferred from donating plasma. By excluding previously deferred plasma or blood donors, this system further ensures the safety of plasma and plasma products. Implementation of a European NDDR is being discussed by several European regulatory authorities.
CSL Behring complies with all government regulations set forth by the countries in which we operate, which include, but are not limited to:
- United States: US Food and Drug Administration, US Clinical Laboratory Improvement Act (CLIA) and Occupational Safety and Health Act (OSHA)
- Europe: European Medicines Agency
- Germany: German Health Authority, Paul Ehrlich Institute and regional authorities
- United Kingdom: Medicines and Healthcare Products Regulatory Agency
- Japan: Ministry of Health, Labor and Welfare
CSL Behring quality systems were among the first in the industry to be certified by the Plasma Protein Therapeutics Association (PPTA). Periodic audits ensure continued compliance with certification program standards.
- PPTA Quality, Safety, Excellence, Assurance and Leadership (QSEAL) certification for excellence in manufacturing
- International Quality Plasma Program (IQPP) certification for adherence to plasma collection standards
- National Donor Deferral Registry (NDDR) participation to
monitor deferred donors in the US