Title 21, Part 212 — Current Good Manufacturing Practice for Positron Emission Tomography Drugs
16 sections
Section 212.1
What are the meanings of the technical terms used in these regulations?
Section 212.2
What is current good manufacturing practice for PET drugs?
Section 212.5
To what drugs do the regulations in this part apply?
Section 212.10
What personnel and resources must I have?
Section 212.20
What activities must I perform to ensure drug quality?
Section 212.30
What requirements must my facilities and equipment meet?
Section 212.40
How must I control the components I use to produce PET drugs and the containers and closures I package them in?
Section 212.50
What production and process controls must I have?
Section 212.60
What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
Section 212.61
What must I do to ensure the stability of my PET drug products through expiry?
Section 212.70
What controls and acceptance criteria must I have for my finished PET drug products?
Section 212.71
What actions must I take if a batch of PET drug product does not conform to specifications?
Section 212.80
What are the requirements associated with labeling and packaging PET drug products?
Section 212.90
What actions must I take to control the distribution of PET drug products?
Section 212.100
What do I do if I receive a complaint about a PET drug product produced at my facility?
Section 212.110
How must I maintain records of my production of PET drugs?