References

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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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References

Code of Federal Regulations. Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart B, Section 211.22 "Responsibilities of quality control unit." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-B/section-211.22.
Code of Federal Regulations. Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart B, Section 211.25 "Personnel qualifications." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-B/section-211.25.
Code of Federal Regulations. Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart E "Control of Components and Drug Product Containers and Closures." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211?toc=1.
Code of Federal Regulations. Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart J "Records and Reports." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J.
Code of Federal Regulations. Part 600-Biological Products: General, Subpart B, Section 600.10 "Personnel." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-B/section-600.10.
Code of Federal Regulations. Part 600-Biological Products: General, Subpart B, Section 600.15 "Temperatures during shipment." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-B/section-600.15.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart B, Section 606.20 "Personnel." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-B/section-606.20.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart C, Section 606.40 "Facilities." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-C/section-606.40.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart D, Section 606.60 "Equipment." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-D/section-606.60.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart D, Section 606.65 "Supplies and reagents." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-D/section-606.65.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart F, Section 606.100 "Standard operating procedures." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-F.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart G, Section 606.121 "Container label." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-G/section-606.121.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart G, Section 606.122 "Circular of information." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-G/section-606.122.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart G, Section 610.60 "Container label." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-610/subpart-G/section-610.60.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart H, Section 606.140 "Laboratory controls." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-H/section-606.140.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart H, Section 606.151 "Compatibility testing." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-H/section-606.151.
Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart I, Section 606.170 "Adverse reaction file." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-I/section-606.170.
Code of Federal Regulations. Part 607-Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices. Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-607.
Code of Federal Regulations. Part 610-General Biological Products Standards. Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-610.
Code of Federal Regulations. Part 640-Additional Standards for Human Blood and Blood Products. Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-640.
Code of Federal Regulations. Part 640-Additional Standards for Human Blood and Blood Products, Subpart A, Section 640.2 "General requirements." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-640/subpart-A/section-640.2.
Code of Federal Regulations. Part 640-Additional Standards for Human Blood and Blood Products, Subpart B "Red Blood Cells." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-640/subpart-B.
Code of Federal Regulations. Part 640-Additional Standards for Human Blood and Blood Products, Subpart C "Platelets." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/part-640/subpart-C.
Code of Federal Regulations. Part 640-Additional Standards for Human Blood and Blood Products, Subpart D "Plasma." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-640/subpart-D.
Code of Federal Regulations. Part 640-Additional Standards for Human Blood and Blood Products, Subpart F "Cryoprecipitate." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/part-640/subpart-F.
Code of Federal Regulations. Part 640-Additional Standards for Human Blood and Blood Products, Subpart L, Section 640.120 "Alternative procedures." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-640/subpart-L/section-640.120.
U.S. Food and Drug Administration. Code of Federal Regulations Title 21. Available at: https://www.ecfr.gov/current/title-21.
World Health Organization. WHO technical report series, No. 961,2011. WHO guidelines on good manufacturing practices for blood establishments. Geneva, Switzerland: World Health Organization; 2011.