21 CFR PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
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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?
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?
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?
21 CFR Part 212 CGMP for Positron Emission Tomography Drugs:
