Part 212 Current Good Manufacturing Practice 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? 10 × 483

Subpart C - Quality Assurance

• § 212.20   What activities must I perform to ensure drug quality? 102 × 483

Subpart D - Facilities and Equipment

• § 212.30   What requirements must my facilities and equipment meet? 84 × 483

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? 20 × 483

Subpart F - Production and Process Controls

• § 212.50   What production and process controls must I have? 58 × 483

Subpart G - Laboratory Controls

• § 212.60   What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products? 55 × 483
• § 212.61   What must I do to ensure the stability of my PET drug products through expiry? 3 × 483

Subpart H - Finished Drug Product Controls and Acceptance

• § 212.70   What controls and acceptance criteria must I have for my finished PET drug products? 13 × 483
• § 212.71   What actions must I take if a batch of PET drug product does not conform to specifications? 19 × 483

Subpart I - Packaging and Labeling

• § 212.80   What are the requirements associated with labeling and packaging PET drug products? 1 × 483

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? 5 × 483

Subpart L - Records

• § 212.110   How must I maintain records of my production of PET drugs? 3 × 483