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Title 21 - Title 21

Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

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BIOLOGICS - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

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17 sections

§606.100 - Standard operating procedures.

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§606.110 - Plateletpheresis, leukapheresis, and plasmapheresis.

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§606.120 - Labeling, general requirements.

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§606.121 - Container label.

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§606.122 - Circular of information.

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§606.140 - Laboratory controls.

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§606.145 - Control of bacterial contamination of platelets.

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§606.151 - Compatibility testing.

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§606.160 - Records.

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§606.165 - Distribution and receipt; procedures and records.

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§606.170 - Adverse reaction file.

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§606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.

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§606.20 - Personnel.

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§606.3 - Definitions.

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§606.40 - Facilities.

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§606.60 - Equipment.

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§606.65 - Supplies and reagents.

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