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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 606 - Current Good Manufacturing Practice for Blood and Blood Components |
| Subpart A - General Provisions |
| § 606.3 - Definitions. |
| Subpart B - Organization and Personnel |
| § 606.20 - Personnel. |
| Subpart C - Plant and Facilities |
| § 606.40 - Facilities. |
| Subpart D - Equipment |
| § 606.60 - Equipment. |
| § 606.65 - Supplies and reagents. |
| Subpart E - XXX |
| Subpart F - Production and Process Controls |
| § 606.100 - Standard operating procedures. |
| § 606.110 - Plateletpheresis, leukapheresis, and plasmapheresis. |
| Subpart G - Additional Labeling Standards for Blood and Blood Components |
| § 606.120 - Labeling, general requirements. |
| § 606.121 - Container label. |
| § 606.122 - Circular of information. |
| Subpart H - Laboratory Controls |
| § 606.140 - Laboratory controls. |
| § 606.145 - Control of bacterial contamination of platelets. |
| § 606.151 - Compatibility testing. |
| Subpart I - Records and Reports |
| § 606.160 - Records. |
| § 606.165 - Distribution and receipt; procedures and records. |
| § 606.170 - Adverse reaction file. |
| § 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services. |