21 CFR Part 606
PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
- PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter F—Biologics
- 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 [Reserved]
- 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.
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