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