21 C.F.R. PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
Subpart A--GENERAL PROVISIONS
Subpart B--ORGANIZATION AND PERSONNEL
Subpart C--PLANT AND FACILITIES
Subpart D--EQUIPMENT
Subpart E--[RESERVED]
Subpart F--PRODUCTION AND PROCESS CONTROLS
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| Standard operating procedures.
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| Plateletpheresis, leukapheresis, and plasmapheresis.
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Subpart G--FINISHED PRODUCT CONTROL
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| Labeling, general requirements.
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Subpart H--LABORATORY CONTROLS
Subpart I--RECORDS AND REPORTS
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| Distribution and receipt; procedures and records.
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| Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.
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