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Regulations
Part 606: Current Good Manufacturing Practice for Blood and Blood Components
Subpart B: Organization and Personnel
21 CFR 606.20 - Personnel.
21 CFR 606.20(b) - (b) The personnel responsible for the collection, processing, compatibility testing, storage or d...
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Subpart D: Equipment
21 CFR 606.65 - Supplies and reagents.
21 CFR 606.65(e) - (e) Supplies and reagents shall be used in a manner consistent with instructions provided by the ...
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21 CFR 606.60 - Equipment.
21 CFR 606.60(a) - (a) Equipment used in the collection, processing, compatibility testing, storage and distribution...
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Subpart F: Production and Process Controls
21 CFR 606.100 - Standard operating procedures.
21 CFR 606.100(c) - (c) All records pertinent to the lot or unit maintained pursuant to these regulations shall be re...
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Subpart I: Records and Reports
21 CFR 606.160 - Records.
21 CFR 606.160(a) - (a)
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21 CFR 606.165 - Distribution and receipt; procedures and records.
21 CFR 606.165(b) - (b) Distribution records shall contain information to readily facilitate the identification of th...
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Part 610: General Biological Products Standards
Subpart E: Testing Requirements for Relevant Transfusion-Transmitted Infections
21 CFR 610.40 - Test requirements.
21 CFR 610.40(a) - (a) Human blood and blood components
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21 CFR 610.40(b) - (b) Testing using one or more licensed, approved, or cleared screening tests. To perform testing...
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Part 640: Additional Standards for Human Blood and Blood Products
Subpart B: Red Blood Cells
21 CFR 640.11 - General requirements.
21 CFR 640.11(a) - (a) Storage. Immediately after processing, the Red Blood Cells shall be placed in storage and ma...
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