PTI - international

I. Overview of GMPs in the U.S., EU and Japan

• Review the historical development of GMPs in each region
• Examine problems associated with inconsistencies across regions
• Outline recent efforts to harmonize GMP requirements
  • International Conference on Harmonization (ICH)
  • Development and implementation of ICH guidelines
• Assess significance and current status of 21 CFR Part 26 (Mutual Recognition Agreement)
• Compare GMP requirements and enforcement in the U.S., EU and Japan versus "rest of world" countries

Discussion: Benefits of Harmonization and Sharing of Regulatory Inspections Among Agencies

II. Comply with FDA GMPs for Pharmaceuticals - 21 CFR Parts 210 and 211

• Review and interpret FDA cGMP requirements
• Highlight the components of the quality system:
  • production system
  • packaging and labeling
  • facilities and equipment
  • laboratory controls
  • materials
  • personnel and training
• Examine in detail various cGMP requirements (e.g., process validation, equipment validation, computer system validation, etc.)

Exercise: Develop a Matrix for the Comparison of International GMPs. Note: This Exercise Builds Throughout the Course. Start with the FDA GMPs for Pharmaceuticals

III. Comply with FDA GMPs for Medical Devices – 21 CFR Part 820

• Outline the Quality System Regulation
  • CAPA
  • quality audits
  • design controls
  • facilities and equipment
  • material control
  • change control
  • production and process control

Exercise: Continue to Develop a Matrix for the Comparison of International GMPs. Add 21 CFR Part 820 Requirements and Compare with Parts 210-211