Regulatory library
21 CFR Part 212
Part 212 is the CGMP rule for positron emission tomography (PET) drugs, which replaces Part 211 for them. It asks for equipment suited to its use, with cleaning, maintenance and calibration under written procedures.
ValDoc's library holds 1 provision of 21 CFR Part 212. This page is guidance in our words. The regulation's own text governs.
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Thirty minutes. Bring one piece of equipment.
Provisions in ValDoc's library
21 CFR 212.30; 212.40-212.50; 212.60-212.70; 212.110
Unchanged since
What requirements must my facilities and equipment meet?; How must I control the components I use to produce PET drugs and the containers and closures I package them in?; What production and process controls must I have?; What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?; What must I do to ensure the stability of my PET drug products through expiry?; What controls and acceptance criteria must I have for my finished PET drug products?; How must I maintain records of my production of PET drugs?
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.