QMS for Blood and Tissue Services
Industry-leading quality and compliance solutions for Blood and Tissue banks and services
Blood and tissue products are essential to the treatment of numerous diseases and conditions. It’s critical to ensure a safe and adequate supply to hospitals and patients. As a result, regulatory agencies have progressively strengthened the safeguards to protect patients from unsuitable blood, plasma, tissues, and organs.
Blood and tissue companies are regulated by the FDA, with a multitude of regulations and guidance from a variety of centers. From the Center of Biologics Evaluation & Research (CBER), 21 CFR Part 600 covers licensing, deviation reporting, advertising and labeling. It also establishes standards for personnel, the physical building and equipment as well as standards for animals and their care. Finally, it establishes standards for the maintenance of records, the retention of samples, and post-market reporting of adverse experiences.
21 CFR Part 606 is specific to cGMPs for Blood and Blood components. It too has general provisions regarding the organization, personnel, plant and facilities, equipment, labeling and records. However, it adds production and process controls as well as laboratory controls. It points to 21 CFR Part 640 where organizations dealing with blood and blood products can find specifics for whole blood and the collection, testing, and modification of whole blood. Current Good Tissue Practices are covered in 21 CFR Part 1271 along with information on procedures for registration and listing as well as donor eligibility. Finally, the Public Health Services Act (Section 361) gives the FDA authority to issue regulations to prevent the introduction, transmission, or spread of communicable disease. CBER is responsible for regulating this section.
CBER isn’t alone in regulating blood and tissue. The Center for Drug Evaluation and Research (CDER) gets involved with 21 CFR Parts 210 and 211, and 21 CFR Part 4 can also apply when a combination product contains blood, blood components, or tissue. Diagnostic testing aids in the screening and monitoring of specific diseases or conditions. To this end, the Clinical Laboratory Improvement Amendment (CLIA) regulates laboratory testing and requires clinical labs to be certified by their state via the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
There are other quality standards followed in the United Stated as well. Outside of the US, the European Medicines Agency (EMA) oversees blood and tissue products in collaboration with the World Health Organization (WHO). The World Health Organization's Blood Regulators Network (BRN), established in 2006, is responsible for the regulation of blood, blood products, and related In-Vitro Diagnostics (IVDs).
Additionally, blood, plasma and tissue are highly perishable products. Donors must be constantly recruited to replenish the supply, while blood and tissue organizations must maintain the quality and traceability of that supply.
Blood, plasma, and tissue companies have typically used a variety of manual and semi-automated systems to manage quality and compliance efforts. While these systems have created some efficiency within their functional areas, they lack the integration capabilities necessary to ensure complete visibility and consistency through the organization.
No matter where you in terms of regulatory inspection readiness, Pilgrim Quality Solutions, an IQVIA company, can help with blood safety and quality regulation. Whether your organization needs to develop a risk-based CAPA process, ensure that your team is adequately trained and following procedures, keep documents under control, or structure your quality system data to support quality metrics and reporting, Pilgrim SmartSolve® provides integrated quality management tools to achieve your goals.
SmartSolve Solutions for Blood and Tissue
Plan, manage, and conduct internal, supplier, and regulatory audits.
Implement a risk-based corrective and preventive action process for regulatory compliance.
Ensure consistent and compliant change throughout the organization.
Streamline complaint handling and regulatory reporting.
Build a foundation for quality and compliance.
Capture, resolve, and track both supplier and internal defects.
Evaluate and manage product recalls and corrections.
Identify and focus on the suppliers that matter most.
Ensure a competent, compliant workforce.
Quality Intelligence Brings Actionable Insight
SmartSolve lets you gain insight over your quality management operations with built-in tools for monitoring key processes. You can keep tabs on trends, share reports throughout your organization, or get more hands-on with data analysis with our quality intelligence tools.
Tools to Tailor, Extend, and Integrate Quality Processes
Pilgrim’s QMS solutions for Blood and Tissue banks and services are developed on SmartSolve's Platform for Compliance. SmartSolve's Configuration Tools, Platform Services, Enterprise Integration capabilities make it easy to tailor, extend, and integrate processes as the demands on your quality management system grow. Plus, Pilgrim's secure, cloud-based deployment options and automated validation tools help your team get up and running on new processes quickly.