Establishment Standards

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Biologics
  6. Biological Products: General
  7. Establishment Standards

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Section
600.10

Personnel.

Section
600.11

Physical establishment, equipment, animals, and care.

Section
600.12

Records.

Section
600.13

Retention samples.

Section
600.14

Reporting of biological product deviations by licensed manufacturers.

Section
600.15

Temperatures during shipment.