21 CFR Part 212 CGMP Guidelines for Positron Emission Tomography Drugs

21 CFR Part 212 CGMP Guidelines for Positron Emission Tomography Drugs

21 CFR Part 212 Current Good Manufacturing Practice Guidelines for Positron Emission Tomography Drugs

Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used in, and the facilities and controls used for, the production, quality assurance, holding, or distribution of PET drugs intended for human use. Current good manufacturing practice is intended to ensure that each PET drug meets the requirements of the act as to safety and has the identity and strength, and meets the quality and purity characteristics, that it is supposed to have.

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Table of Contents

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?

21 CFR Part 212 CGMP Guidelines for Positron Emission Tomography Drugs:

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