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Current r Good Manufacturing Practices in Manufacturing i Processing Packaging and Holding of Drugs
General Provisions Subpart A
Organization and Personnel Subpart B
15 other sections not shown
active ingredient agency analysis appropriate approved areas assay assure batch number batch production batch record bulk certificate of analysis CGMP chemical cleaning completed compliance components containers and closures control number copy Cosmetic Act current good manufacturing data fields defects designed determined document dosage form Drug Administration drug product containers duct employee ensure equipment established expiration date facturing Federal Food finished firm Food and Drug function identified identity in-process materials inspection inspector labels and labeling laboratory lot number maintained Manufacturing Practices master formula maximum contaminant level ment methods name and number number assigned packaging and labeling packaging operations packing penicillin performed person personnel pharmaceutical printing processing product recall quality control unit quantity quarantine raw materials recall regulations rejected release repackers reprocessing requirements reserpine responsible samples shipment signature specifications standards sterile storage supervisor supplier tablets tion total quality control United States Pharmacopeia utilized written procedures