e-CFR data is current as of September 24, 2020
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER C—DRUGS: GENERAL PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
Subpart A—GENERAL PROVISIONS
|
| What are the meanings of the technical terms used in these regulations? |
|
|
| What is current good manufacturing practice for PET drugs? |
|
|
| To what drugs do the regulations in this part apply? |
|
Subpart B—PERSONNEL AND RESOURCES
|
| What personnel and resources must I have? |
|
Subpart C—QUALITY ASSURANCE
|
| What activities must I perform to ensure drug quality? |
|
Subpart D—FACILITIES AND EQUIPMENT
|
| What requirements must my facilities and equipment meet? |
|
Subpart E—CONTROL OF COMPONENTS, CONTAINERS, AND CLOSURES
|
| 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
|
| What production and process controls must I have? |
|
Subpart G—LABORATORY CONTROLS
|
| What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products? |
|
|
| What must I do to ensure the stability of my PET drug products through expiry? |
|
Subpart H—FINISHED DRUG PRODUCT CONTROLS AND ACCEPTANCE
|
| What controls and acceptance criteria must I have for my finished PET drug products? |
|
|
| What actions must I take if a batch of PET drug product does not conform to specifications? |
|
Subpart I—PACKAGING AND LABELING
|
| What are the requirements associated with labeling and packaging PET drug products? |
|
Subpart J—DISTRIBUTION
|
| What actions must I take to control the distribution of PET drug products? |
|
Subpart K—COMPLAINT HANDLING
|
| What do I do if I receive a complaint about a PET drug product produced at my facility? |
|
Subpart L—RECORDS
|
| How must I maintain records of my production of PET drugs? |
|
| 