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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 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 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 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.

U.S. Food and Drug Administration. Code of Federal Regulations Title 21. Available at: http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm.

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.