1. Regulatory Labeling and Marketing

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

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

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

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

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

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