SUBPART G—Laboratory Controls (§212.60 to §212.61) - Title 21 - Food and Drugs CFR - USA Laws Searching

CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER C—DRUGS: GENERAL (parts 200 to 299) > PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS > SUBPART G—Laboratory Controls (§212.60 to §212.61)

SUBPART G—Laboratory Controls (§212.60 to §212.61)

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?