Title 21

PART 212

Part 212 - Current Good Manufacturing Practice For Positron Emission Tomography Drugs

PART 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS Authority:21 U.S.C. 321, 351, 352, 355, 371, 374; Sec. 121, Pub. L. 105-115, 111 Stat. 2296. Source:74 FR 65431, Dec. 10, 2009, unless otherwise noted.

21:4.0.1.1.12.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.12.1.1.1SECTION 212.1
   212.1 What are the meanings of the technical terms used in these regulations
21:4.0.1.1.12.1.1.2SECTION 212.2
   212.2 What is current good manufacturing practice for PET drugs
21:4.0.1.1.12.1.1.3SECTION 212.5
   212.5 To what drugs do the regulations in this part apply
21:4.0.1.1.12.2SUBPART B
Subpart B - Personnel and Resources
21:4.0.1.1.12.2.1.1SECTION 212.10
   212.10 What personnel and resources must I have
21:4.0.1.1.12.3SUBPART C
Subpart C - Quality Assurance
21:4.0.1.1.12.3.1.1SECTION 212.20
   212.20 What activities must I perform to ensure drug quality
21:4.0.1.1.12.4SUBPART D
Subpart D - Facilities and Equipment
21:4.0.1.1.12.4.1.1SECTION 212.30
   212.30 What requirements must my facilities and equipment meet
21:4.0.1.1.12.5SUBPART E
Subpart E - Control of Components, Containers, and Closures
21:4.0.1.1.12.5.1.1SECTION 212.40
   212.40 How must I control the components I use to produce PET drugs and the containers and closures I package them in
21:4.0.1.1.12.6SUBPART F
Subpart F - Production and Process Controls
21:4.0.1.1.12.6.1.1SECTION 212.50
   212.50 What production and process controls must I have
21:4.0.1.1.12.7SUBPART G
Subpart G - Laboratory Controls
21:4.0.1.1.12.7.1.1SECTION 212.60
   212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products
21:4.0.1.1.12.7.1.2SECTION 212.61
   212.61 What must I do to ensure the stability of my PET drug products through expiry
21:4.0.1.1.12.8SUBPART H
Subpart H - Finished Drug Product Controls and Acceptance
21:4.0.1.1.12.8.1.1SECTION 212.70
   212.70 What controls and acceptance criteria must I have for my finished PET drug products
21:4.0.1.1.12.8.1.2SECTION 212.71
   212.71 What actions must I take if a batch of PET drug product does not conform to specifications
21:4.0.1.1.12.9SUBPART I
Subpart I - Packaging and Labeling
21:4.0.1.1.12.9.1.1SECTION 212.80
   212.80 What are the requirements associated with labeling and packaging PET drug products
21:4.0.1.1.12.10SUBPART J
Subpart J - Distribution
21:4.0.1.1.12.10.1.1SECTION 212.90
   212.90 What actions must I take to control the distribution of PET drug products
21:4.0.1.1.12.11SUBPART K
Subpart K - Complaint Handling
21:4.0.1.1.12.11.1.1SECTION 212.100
   212.100 What do I do if I receive a complaint about a PET drug product produced at my facility
21:4.0.1.1.12.12SUBPART L
Subpart L - Records
21:4.0.1.1.12.12.1.1SECTION 212.110
   212.110 How must I maintain records of my production of PET drugs