Regulatory Labeling and Marketing Which ones are involved

Regulatory Labeling and Marketing

Which ones are involved in label design and control? l l l Manufacturing Quality Assurance Quality Control l l Chemistry Microbiology Inspection Regulatory l l l Audits Clinical Trials FDA filings l Materials Management l l l l Receiving Distribution Inventory Control Human Resources Finance Sales and Marketing Management Research and Development

Label Design l All departments who have developed or will have to manufacture and release the product will be involved in label design

Label Approval and Control l Regulatory, Quality Assurance and Marketing are the groups who “approve” the final label l Materials, QA, QC, and Mfg. “control” the label from receipt, through inspection to application to product, through finished product inspection.

Labeling and Packaging Control l Why would this be an area to be audited? Label text: pre-approved and inspected l Label adhesion: pre-approved and inspected l Label accountability: verified at every step l Package insert content: pre-approved and inspected l Package insert accountability: verified at every step l l CONTROLLED TO PREVENT MIXUPS

Label Text l Fixed Text l Text that does not change with each lot l Company name, address, l Product Name, storage temp, ingredients l Variable Text l Text that does change with each lot l Lot number and or serial number l Expiration Date l Concentration or Potency

Marketing Information l Labels and Package inserts are highly controlled l Marketing information such as product informational flyer l Approved by Regulatory and Marketing l Marketing distributes w/out control