21 CFR Part 212 Current Good Manufacturing Practice Guidelines for Positron Emission Tomography Drugs
Subpart A - General Provisions
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?
Subpart B - Personnel and Resources
212.10 What personnel and resources must I have?
212.20 What activities must I perform to ensure
drug quality?
Subpart D - Facilities and Equipment
212.30 What requirements must my facilities and
equipment meet?
Subpart E - Control of Components, Containers, and Closures
Subpart F - Production and Process Controls
212.50 What production and process controls must
I have?
Subpart G - Laboratory Controls
212.61 What must I do to ensure the stability of
my PET drug products through expiry?
Subpart H - Finished Drug Product Controls and Acceptance
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?
Subpart I - Packaging and Labeling
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?
Subpart K - Complaint Handling
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?