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?