SAFETY & QUALITY IN THE BIOSCIENCE DIVISION
DONATION
Donor selection

Grifols only uses plasma from qualified donors (for more information, see the “Donor Profile” section) collected in centers approved by the relevant health authorities. Donors are subject to annual medical exams and routine health screenings before every donation. The company does not discriminate against potential donors on the basis of ethnicity, gender or socioeconomic status. It only accepts healthy donors who are committed to the donation process, have proof of a permanent local residence and meet rigorous health and safety criteria. Grifols plasma centers are also subject to regular inspections.

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Analysis of donated plasma

All units of donated plasma are analyzed in FDA-licensed laboratories to guarantee the safety and quality of source plasma. More than 10 analyses are performed on each unit of plasma, including tests for hepatitis A, B or C, HIV and parvovirus B19, using highly sensitive techniques such as NAT (Nucleic Acid Testing) to detect pathogens and ELISA (Enzyme-Linked Immunosorbent Assay) to detect viral antigens or antibodies. Once the plasma units are in production, every batch is tested at various stages during the production process. In total, 18 different analyses are performed.

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60-day inventory hold

All plasma units that pass the initial viral testing are subject to a 60-day inventory hold before being released into production. The results of the hold sample are verified against the new donation to reconfirm the absence of viruses and pathogens.

Main Relevant Regulations
  • WHO: recommendations for the production, control and regulation of human plasma for fractionation (WHO Technical Report Series, No. 941)
  • Directive 2002/98/CE that sets the standards for the quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
  • EMA Guideline on plasma-derived Medicinal products
  • 21CFR Part 640: additional standards for human blood and blood components
  • Local regulations in countries where hemoderivatives are distributed
  • PPTA standards adhered to voluntarily by Grifols
  • European Pharmacopoeia
PRODUCTION
Quality management systems in all production facilities

After plasma has been approved for production, the manufacturing process begins. This process mainly entails the fractionation or protein separation process; purification; specific viral-inactivation processes; sterile filling; and secondary packaging. All operations are carried out in accordance with Global Manufacturing Practices (GMP).

All of Grifols’ manufacturing plants have a Pharmaceutical Quality System and a strict quality assurance system.

Grifols’ manufacturing processes are also subject to a rigorous internal quality-control program to guarantee the quality, safety and efficacy of every batch produced.

Elimination of viruses and other pathogens

During the production phase, approved plasma undergoes rigorous testing and purification processes, including several pathogen-elimination steps, viral inactivation and viral-removal techniques to guarantee the highest possible levels of safety. Depending on the product, the manufacturing process may include heat treatment, pasteurization, solvent/detergent treatment and/or nanofiltration. 

After purification, the product is sterilized using a proprietary sterile-filling process process developed in-house by Grifols Engineering and considered an industry standard.

Grifols’ manufacturing facilities are not only subject to inspections by the relevant authorities but also have never been closed due to regulatory incompliance.

Main Relevant Regulations
  • Good Manufacturing Practices, European Union
  • Code of Federal Regulations (CFR): 21 CFR 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 601, 610, 630 and 640
  • Good Manufacturing Practices, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
  • European Pharmacopoeia
  • U.S. Pharmacopoeia
  • Local regulations in countries where hemoderivatives are distributed
POST-SALES
Product tracking and traceability

Before releasing any plasma-derived medicine, Grifols identifies product vials with a unique code, which includes a laser etching of the lot number to ensure traceability. Moreover, all products include a holographic seal to verify their inviolability and authenticity.

Grifols also implemented a system to assign unique, traceable numbers to product units in accordance with the applicable rules and regulations of the global markets where it operates as part of its total commitment to regulatory authorities to prevent counterfeits. Its pledge to patient safety includes a robust pharmacovigilance system.

In addition, Grifols voluntarily rolled out the PEDIGRI® system, which provides healthcare professionals detailed information on the plasma used to manufacture a specific unit of product, as well as a certificate of the testing performed. For more than 20 years, Grifols has been the only company to offer information on the source and traceability of its plasma. 

Main Relevant Regulations
  • Good Pharmacovigilance Practices, EMA
  • 21 CFR 50
  • Local regulations in countries where hemoderivatives are distributed
SAFETY & QUALITY management
INTERNAL control framework
  • Grifols’ rigorous safety system for its plasma-derived products resides in the dedication of its highly trained staff; a robust process and product design; leading-edge technologies developed in-house by Grifols Engineering; and full traceability from plasma donation to the final product. Throughout the value chain, the different materials and processes that intervene in production are monitored by Grifols quality-assurance managers. This supervision includes controls in both manufacturing processes and final products to ensure the quality, safety and efficacy of each lot; the review and follow-up of production processes to ensure compliance with best manufacturing practices and promote ongoing improvements; and systems to scale relevant events and take appropriate actions through Grifols’ Quality Committees, which evaluate key performance indicators (KPIs) and quality markers.
  • Grifols also forms part of the National Donor Deferral Registry (NDDR), a voluntary self-regulating initiative to guarantee the quality and safety of plasma that applies to all U.S. donors. This database ensures that all donors who test positive for the viral agents for HIV, HBV, and HCV are permanently prohibited from donating source plasma at participating licensed and industry-certified centers in the U.S. 
External certifications
  • Certifications of Good Business Manufacturing Practices of the European Union, the United States and other countries where required.
  • IQPP & QSEAL Certifications of the Plasma Protein Therapeutics Association (PPTA)
  • International Quality Plasma Program (IQPP) Certification, a voluntary standards program that includes the management of donors and plasma centers. 
  • Quality Standards of Excellence, Assurance and Leadership Certification (QSEAL) that apply to the manufacture of plasma-derived medicines, with voluntary certification and adhesion to the program
Supplier control system
  • Grifols’ Supplier Qualification Management System ensures that all raw materials, including plasma from external providers as well as non-plasma critical suppliers, follow a strict qualification process. The company runs a robust program of routine supplier audits to guarantee compliance with GMP norms and quality standards. In 2019, 188 audits were carried out as part of the qualification and evaluation processes. Audits performed on suppliers of raw materials and services focus on the quality and safety of their products.
In-house and external quality audits
  • Grifols’ senior management implements and maintains an effective organization-wide quality management system. Internal auditors regularly inspect plasma centers, laboratories, manufacturing and storage facilities to ensure compliance with GMP regulations and quality standards.
  • The independent corporate auditing department conducts routine reviews of collected plasma, manufacturing records and other quality-related documentation, in addition to independently overseeing and verifying the company’s operational processes.
  • The U.S. (FDA) and European (EMA) health authorities, among others, periodically inspect all plasma donation centers, production plants, warehouses, laboratories and transport centers. The PPTA regularly inspects Grifols’ collection centers and fractionation plants. 
PLASMA DONATIONS
Reasons to Donate

Plasma donations save lives 

Plasma-derived medicines are used to treat or prevent severe conditions and diseases in various therapeutic areas including pneumology, hematology, neurology, infectious diseases and traumatology. 

Plasma donors help save lives and enhance the quality of life of thousands of patients. As many as 1,300 plasma donations are required to treat just a single patient for one year.

Plasma cannot be manufactured in a lab

Plasma is an essential raw material used in a myriad of hemoderivatives developed to treat and prevent potentially life-threatening diseases and conditions. Due to its complexity, it is impossible to manufacture plasma in a lab and plasma-derived medicines are only possible thanks to the generosity of volunteer donors.


REGULATIONS FOR PLASMA DONATIONS

There are two basic ways to obtain plasma: recovered plasma, derived from a sub-product of collected whole blood; and source plasma procured from a specific plasmapheresis procedure. 

The procurement of source plasma used exclusively for the subsequent manufacture of plasma-derived medicines is strictly regulated by the U.S. Food and Drug Administration (FDA) and other official regulatory authorities. In conjunction with the rigorous legislation and procedures on good manufacturing practices imposed by healthcare entities, the Plasma Protein Therapeutics Association (PPTA) voluntarily establishes and supervises additional norms. In Europe, the European Medicines Agency (EMA) oversees this domain. 

During plasmapheresis, plasma is extracted and blood cells, platelets and other blood components are returned to the donor. In contrast to what happens with blood cells in whole-blood donations, in plasma donations the body can regenerate lost proteins in less than 24 hours.


Quality Control in Plasma Centers

Plasma donation centers are subject to regular quality control and safety standards to guarantee the safety of donors and quality of collected plasma.

Grifols’ requirements for safe donations and detailed information on the plasma donation process are available on www.grifolsplasma.com
GRIFOLS’ COMMITMENT TO DONORS

BASED ON THE UNIVERSAL DECLARATION OF HUMAN RIGHTS

  • Respect for the dignity and inherent rights of donors is an indispensable obligation for Grifols, which endorses, upholds and supports the Universal Declaration of Human Rights (1948), the Helsinki Declaration (1964) and UNESCO’s Universal Declaration on Bioethics and Human Rights (2005).
  • All donors are treated equally, regardless of race, religion, work status and socioeconomic profile.
  • Grifols’ first and foremost priority is the health, safety, well-being and dignity of our donors.

Equal treatment

Grifols applies the same quality and safety criteria in all of its plasma centers and to all donors

  • All donors are subject to the same strict quality and safety standards throughout Grifols’ global network of plasma donation centers without any exceptions.
REQUIREMENTS FOR PLASMA DONORS

Not everyone can become a plasma donor

Grifols’ Donor Profile