PTI - international

Agenda: Day One

• Identify key labeling and packaging issues in pharmaceutical R&D
• Analyze labeling and packaging development processes, including marketing aspects
• Outline roles and responsibilities of development team

Discussion: Review Attendees' Backgrounds and Major Challenges

II. Examine cGMPs for the Manufacture, Packaging and Labeling of Drug Products

• Review FDA drug approval process and general packaging/labeling guidelines
• Discuss the impact of current Good Manufacturing Practices (cGMPs)
• Analyze USP test procedures and requirements
• Explore the FDA's proposed rule for prescription drug labeling

Exercise: Review Industry Warning Letters for Common Packaging and Labeling Deficiencies

III. Analyze the Composition and Manufacture of Drug Packaging Materials

• Identify the types of glass used in manufacturing and drug packaging
• Explore the use of metal in tinplates
• Inspect the nature of plastics and composite films
• Examine the chemical structure of elastomeric material

Exercise: Discuss the Impact of Future Trends on Packaging Material

IV. Implement Comprehensive SOPs for Packaging and Labeling

• Ensure written procedures include set-up of packaging equipment
• Decide what measures should be taken when process AQL limits are exceeded
• Determine precise packaging plans and label control
• Specify documentation and personnel involvement

Exercise: Controls in Packaging and Labeling to Ensure Compliance

V. Validate Pharmaceutical, Medical and Secondary Packaging and Labeling Equipment

• Review the common challenges of the following equipment:
  • bottle unscramblers
  • slat counters
  • desiccant feeders
  • cottoners
  • insert machines
  • capping machines
  • label machines
  • induction sealers
• Discuss the common pitfalls associated with Form-Fill-Seal machines
• Validate air handling systems in packaging rooms and aseptic processing equipment

Exercise: Validation of Packaging Equipment

VI. Determine Appropriate Formats and Styles of Packaging and Labeling

• Examine ease of use, legibility and understandability
• Assess aesthetic properties and analyze barrier properties
• Explore current security features
• Ensure sufficient use and layout of print warnings

Exercise: Review Samples of Packaging Components
Exercise: Examine FDA Guidance for Labeling

VII. Comply with Legal Requirements for Labels and the Labeling Process

• Identify legal issues related to repackaging and relabeling
• Report drug product problems appropriately