The growth of blood and blood component organizations depends on their ability to address key challenges. Donor recruitment, safety and quality, and cost-effective regulatory compliance are critical components that when mismanaged, can severely damage public trust. Overcoming those challenges can be tremendously difficult, particularly when processes are hampered by cumbersome, inefficient management operating systems.
However, today blood organizations are able to more readily ensure compliance with requirements for quality management systems according to GMP. By effectively streamlining all quality and compliance activities, these enterprises are able to protect one of the world's most precious resources - life-giving blood.
21 CFR Part 606, also known as, Current Good Manufacturing Practice For Blood and Blood Components, outlines requirements for blood labeling, laboratories, reporting and recordkeeping. It is meant to ensure that blood and blood components for human use are safe, pure and effective.
This whitepaper shows how Pilgrim's solution can help companies comply to Part 606.