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Chapter 25

Chapter 25. Transfusion Safety and Federal Regulatory Requirements. The Department of Health and Human Services (DHHS). The United States government’s principal health agency for protecting the health of all Americans The Centers for Disease Control and Prevention (CDC)

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Chapter 25

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  1. Chapter 25 Transfusion Safety and Federal Regulatory Requirements

  2. The Department of Health and Human Services (DHHS) • The United States government’s principal health agency for protecting the health of all Americans • The Centers for Disease Control and Prevention (CDC) • The Centers for Medicare and Medicaid Services (CMS) • The National Institutes of Health (NIH) • The Food and Drug Administration (FDA)

  3. Public Health Service Act • The Biologics Control Act (1902) required biological products to be manufactured in a manner that ensured the safety and purity of the product. • In 1970, the definition of a biological product within the PHS Act was expanded to include blood, blood components, and derivatives.

  4. Federal Food, Drug, and Cosmetic Act • Passed in 1938 to further define the government’s regulatory authority • Requires that manufacturers demonstrate a drug is safe and effective before marketing it • Authorizes registration and facility inspections of drug manufacturers • 1997: Food and Drug Administration Modernization Act (FDAMA) enacted to align regulation of biological products and drugs

  5. Food and Drug Administration • Began in 1927 as the Food, Drug, and Insecticide Administration, a law enforcement agency within the USDA. • In 1968, the FDA was transferred to the Public Health Services within what was then known as the Department of Health, Education, and Welfare.

  6. Food and Drug Administration (cont’d) • The authority for biological products was transferred from the NIH to the FDA in 1972. • Since 1972, the FDA has overseen the safety, purity, and potency of the U.S. blood supply. • The FDA ensures that blood and blood component manufacturers conduct their operations and manufacture their products consistent with applicable laws and regulations, including CGMP.

  7. Food and Drug Administration (cont’d) • Five overlapping layers of blood transfusion safety • Donor screening • Blood testing • Donor lists • Quarantine • Problems and deficiencies

  8. Manufacturers, Manufacturing, and Biological Products • Biological product manufacturers are defined as any legal person or entity engaged in the manufacture of biological products subject to licensure under the PHS Act. • Manufacturing for blood and blood products means the collection, preparation, processing, or compatibility testing by chemical, physical, biological,or other procedures of any blood product that meets the definition of a drug as defined in section 201(k) of the Act.

  9. Manufacturers, Manufacturing, and Biological Products (cont’d) • Manufacturing also includes • The manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process • The packaging, labeling, repackaging, or otherwise changing the container, wrapper, or labeling of any blood product package • See 21CFR 607.3(d)

  10. Statutes and Laws • Statutes such as the PHS Act and the FD&C Act require biological product, drug, and device manufacturers to demonstrate to the FDA that their products are safe and effective (for drug products) or safe, pure, and potent (for biological products) before they are marketed in interstate commerce in the United States.

  11. Regulations • Regulations are legally binding on both the manufacturing industry and the government agencies charged with enforcing the laws. • The regulations define specific minimum standards that manufacturers must meet. • They often do not provide specific procedures on how to meet the standards.

  12. Regulations (cont’d) • Proposed and final regulations are published in the Federal Register (FR) under the authority of the Administrative Procedure Act. • FDA regulations are codified in Title 21 of the CFR. • The regulations applicable to blood and blood components are found in Subchapter F, Parts 600-680, and Subchapter C, Parts 210-211, of Title 21 of the CFR.

  13. Guidance Documents • Describe the agency’s interpretation of or policy on regulations • The recommendations in guidance documents are not legally binding on the manufacturing industry or other government agencies. • However, the recommendations in FDA guidance documents often become the industry standard of practice.

  14. Guidance Documents (cont’d) • Guidance documents are developed and issued under the Good Guidance Practices (GGP) regulations (21 CFR 10.115). • GGP regulations allow for two types of guidance documents: Level 1 and Level 2. • Level I Guidance Documents (21 CFR 10.115(c)(1)) • Level 2 Guidance Documents (21 CFR 10.115(c)(2))

  15. Center for Biologics Evaluation and Research (CBER) • Regulates blood and blood components • The Office of Blood Research and Review (OBRR) regulates the following products • Blood components for transfusion • Blood components for further manufacturing • Medical devices used for blood component collection and manufacturing

  16. Registration • The FD&C Act requires manufacturers to register their establishments with the FDA and list the products they manufacture. • Regulations for blood establishment registration are found in the CFR (21 CFR 607). • Many blood establishments (including hospital and community blood banks) are required to register with the FDA (21 CFR 607.20).

  17. Registration (cont’d) • Registered establishments are required to update their registration each year (21 CFR 607.21). • All registered establishments are responsible for complying with the applicable FDA regulations, including CGMP and applicable product standards. • All are routinely inspected by FDA investigators.

  18. Licensure • The PHS Act requires a biologics license to be in effect if a manufacturer wants to distribute biological products in interstate commerce (21 CFR 601.2(d)). • The review of a Biologics License Application (BLA) involves two steps and numerous activities.

  19. Licensure (cont’d) • Licensed manufacturers are responsible for complying with all applicable FDA regulations, including CGMP and applicable product standards, and are inspected by FDA investigators at least once every 2 years (21 CFR 600.21).

  20. Inspection Authorities • PHS and FD&C Acts have the statutory provisions granting the FDA the authority to enter biological product manufacturing facilities for the purposes of conducting inspections. • The FDA conducts pre-license and pre-approval inspections, routine CGMP inspections, and for-cause inspections.

  21. Inspection Procedures • CBER and ORA investigators conduct pre-license and pre-approval inspections of manufacturing facilities that have submitted a BLA or a supplement to an approved BLA. • Inspections take place at least once every 2 years (21 CFR 600.21).

  22. Inspection Procedures (cont’d) • Both significant and less serious observations, as well as any discussions with the manufacturer, are included in the Establishment Inspection Report (EIR) prepared by the FDA investigators. • Facilities must come into compliance after inspection.

  23. Enforcement Actions • When violations exist, the manufacturer is often given an opportunity for voluntary correction before enforcement actions. • Types of FDA actions • Advisory • Administrative • Judicial

  24. Current Good Manufacturing Regulations • CGMP regulations specific for blood and blood components are found in 21 CFR Part 606. • They describe the minimum current practice and require all manufacturing facilities to implement and follow CGMP requirements. • The FD&C Act provides that a medical device is adulterated if the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation do not conform.

  25. Current Good Manufacturing Regulations (cont’d) • The FDA has issued device CGMP regulations in the Quality System Regulation found in 21 CFR 820. • Blood and blood component manufacturers must follow both the CGMP regulations in 21 CFR 210-211, and the more specific CGMP regulations for blood and blood components. • The CGMP regulations include the elements of quality assurance, quality control, and process validation.

  26. Quality Control Unit (QCU) • The QCU has the responsibility and authority to • Approveor reject all components, containers, closures, labeling,and drug products • Review production records for accuracy and completeness • Investigate errors and deviations • Review and approve standard operating procedures

  27. Quality Reviews • The CGMP regulations require manufacturers to retain manufacturing and blood collection records, such as donor selection records (21 CFR 211.180 and 606.160). • At least annually, the data from written records and quality standards of each product must be reviewed to determine the need for changes in product specifications or manufacturing or control procedures.

  28. Quality Reviews (cont’d) • The QCU or other assigned individuals are responsible for the quality activities, including the annual reviews. • The review should identify trends that could lead to the release of an unsuitable product. • The QCU should share the results of the review with the management of the manufacturing operations in order to correct and prevent ongoing problems.

  29. Additional Requirements of Biological Product Manufacturing • All biological product manufacturers must comply with all applicable biologics regulations in the CFR. • Alternative Procedures (“Variances”) • Alternative procedure that is incorporated into blood establishment SOPs • An exception that is a singular event related to a specific emergency situation

  30. Additional Requirements of Biological Product Manufacturing (cont’d) • Contract Manufacturing • One manufacturer may employ the services of a contract manufacturer to perform some or all of the product manufacturing steps. • Short Supply Arrangements • Arrangements for the partial manufacture of a biological product at an unlicensed facility under controlled conditions.

  31. Additional Requirements of Biological Product Manufacturing (cont’d) • Biological Product Deviation Reporting • Deviations from CGMP or unexpected events in a manufacturing operation that may adversely affect the safety, purity, or potency of the product • Product Recalls • Classified as a Class I, II,or III based on the potential for a product to cause serious health problems

  32. Additional Requirements of Biological Product Manufacturing (cont’d) • Fatality Reporting • A requirement to formally notify CBER within 7 days after a patient fatality is confirmed • Medical Devices • CBER regulation of medical devices used in the collection, processing, testing, manufacturing, and administration of blood, blood components, human cells, tissues, and cellular- and tissue-based product

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