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Transcript
Regulatory Labeling and Marketing Which ones are involved in label design and control? Manufacturing Quality Assurance Quality Control Chemistry Microbiology Inspection Regulatory Audits Clinical Trials FDA filings Materials Management Receiving Distribution Inventory Control Human Resources Finance Sales and Marketing Management Research and Development Label Design All departments who have developed or will have to manufacture and release the product will be involved in label design Label Approval and Control Regulatory, Quality Assurance and Marketing are the groups who “approve” the final label Materials, QA, QC, and Mfg. “control” the label from receipt, through inspection to application to product, through finished product inspection. Labeling and Packaging Control Why would this be an area to be audited? Label text: pre-approved and inspected Label adhesion: pre-approved and inspected Label accountability: verified at every step Package insert content: pre-approved and inspected Package insert accountability: verified at every step CONTROLLED TO PREVENT MIXUPS Label Text Fixed Text Text that does not change with each lot Company name, address, Product Name, storage temp, ingredients Variable Text Text that does change with each lot Lot number and or serial number Expiration Date Concentration or Potency Marketing Information Labels and Package inserts are highly controlled Marketing information such as product informational flyer Approved by Regulatory and Marketing Marketing distributes w/out control
