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Radiological & Environmental Management (REM) is responsible for monitoring the record keeping, inventory, security, and disposal of controlled substances.
The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Similar concepts apply to bulk drugs. This inspection guide supplements other inspectional information contained in other agency inspectional guidance documents.