21 CFR Part 212
CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
June 25, 2020
Subpart
A
General Provisions
Subpart
B
Personnel and Resources
Subpart
C
Quality Assurance
Subpart
D
Facilities and Equipment
Subpart
E
Control of Components, Containers, and Closures
Subpart
F
Production and Process Controls
Subpart
G
Laboratory Controls
Subpart
H
Finished Drug Product Controls and Acceptance
Subpart
I
Packaging and Labeling
Subpart
J
Distribution
Subpart
K
Complaint Handling
Subpart
L
Records