PTI - international

VIII. Comply with Bar Code Requirements

• Define the FDA's expectations regarding bar codes for human drug products
• Identify solutions to technical challenges raised by bar code requirements
• Implement strategies to achieve and maintain compliance

Exercise: Examine the FDA's New Bar Code Requirements

IX. Implement Safety Strategies and Prevent Liability Issues

• Explain the liability issues associated with labeling
• Analyze the impact of Direct-To-Consumer (DTC) advertising
• Include post-marketing and Phase IV study data in package inserts
• Incorporate conversion of terminology for safety information
• Ensure accurate and distinct labeling and prevent mislabeling

Exercise: Review Historical Case Studies of Medication Errors Related to Labeling

X. Ensure Packaging and Labeling Suppliers Comply with FDA Requirements

• Establish metrics to evaluate an outsource provider
• Conduct an efficient pre-qualification process
• Determine responsibilities of suppliers and vendors
• Ensure compliance with test requirements
• Establish the role of the QA group

Exercise: Strategies to Ensure Supplier Compliance

XI. Implement Formal Quality Test Procedures and Criteria

• Validate testing data for product shelf-life
• Ensure the package protects the product
• Implement techniques for changes in batch size
• Examine trending data

Exercise: Strategies to Prevent and Handle Product Deficiencies

XII. Implement Clinical Protocol Requirements for Packaged and Labeled Products

• Prepare for the manufacture of clinical trial material
• Examine manufacturing techniques for various drug product types
• Analyze storage labeling and dispensing
• Evaluate label control and packaging plans
• Ensure compliance with test requirements

XIII. Prepare for an FDA Inspection

• Review the cGMPs that affect clinical supply manufacturing
• Ensure proper documentation
• Implement training for Standard Operating Procedures
• Discuss the impact of OOS results on packaging and labeling

Exercise: Conduct a Systems-Based Inspection of Your Packaging and Labeling Operation