21 CFR Part 212
PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
- PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter C—Drugs: General
- 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?
- Subpart C—Quality Assurance
- § 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
- § 212.40 How must I control the components I use to produce PET drugs and the containers and closures I package them in?
- Subpart F—Production and Process Controls
- § 212.50 What production and process controls must I have?
- Subpart G—Laboratory Controls
- § 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?
- 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?
- Subpart J—Distribution
- § 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?
- Subpart L—Records
- § 212.110 How must I maintain records of my production of PET drugs?
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