|
Section 212.1
|
What is current good manufacturing practice for PET drugs? |
|
Section 212.2
|
To what drugs do the regulations in this part apply? |
|
Section 212.5
|
What personnel and resources must I have? |
|
Section 212.10
|
What activities must I perform to ensure drug quality? |
|
Section 212.20
|
What requirements must my facilities and equipment meet? |
|
Section 212.30
|
How must I control the components I use to produce PET drugs and the containers and closures I package them in? |
|
Section 212.40
|
What production and process controls must I have? |
|
Section 212.50
|
What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products? |
|
Section 212.60
|
What must I do to ensure the stability of my PET drug products through expiry? |
|
Section 212.61
|
What controls and acceptance criteria must I have for my finished PET drug products? |
|
Section 212.70
|
What actions must I take if a batch of PET drug product does not conform to specifications? |
|
Section 212.71
|
What are the requirements associated with labeling and packaging PET drug products? |
|
Section 212.80
|
What actions must I take to control the distribution of PET drug products? |
|
Section 212.90
|
What do I do if I receive a complaint about a PET drug product produced at my facility? |
|
Section 212.100
|
How must I maintain records of my production of PET drugs? |
|
Section 212.110
|
Drug products withdrawn or removed from the market for reasons of safety or effectiveness |