TITLE 21--FOOD AND 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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