Source: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr212_main_02.tpl
Timestamp: 2014-10-24 12:42:12
Document Index: 693523732

Matched Legal Cases: ['art 212', 'ART 212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212', '§212']

Title 21 → Chapter I → Subchapter C → Part 212TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)SUBCHAPTER C—DRUGS: GENERALPART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
§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?
§212.10
What personnel and resources must I have?
§212.20
What activities must I perform to ensure drug quality?
§212.30
What requirements must my facilities and equipment meet?
§212.40
How must I control the components I use to produce PET drugs and the containers and closures I package them in?
§212.50
What production and process controls must I have?
§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?
§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?
§212.80
What are the requirements associated with labeling and packaging PET drug products?
§212.90
What actions must I take to control the distribution of PET drug products?
§212.100
What do I do if I receive a complaint about a PET drug product produced at my facility?
§212.110
How must I maintain records of my production of PET drugs?