PTI - international

IV. Comply with ICH Guidelines for Good Manufacturing Practice

• Examine Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Outline documentation requirements
• Prepare for inspections by understanding regulatory authorities' expectations and highlighting areas that are frequently subject to inspection
• Prepare for future of harmonization by understanding future directions and possible expansion

Exercise: Continue to Develop a Matrix for the Comparison of International GMPs. Add ICH Guidelines and Compare with U.S. Regulations

V. Comply with EU GMPs

• Examine the regulatory system in the EU
• Review and interpret the EU GMP Guide (Volume 4)
• Basic Requirements, Chapters 1 thru 9 (quality management, personnel, premise and equipment, documentation, production, quality control, contract manufacture and analysis, complaints and product recall, self inspection)
• Annexes 1-19 (with emphasis on Annex 11, computerized systems; Annex 15, qualification and validation; Annex 16, certification by a qualified person and batch release; Annex 18, good manufacturing practice for active pharmaceutical ingredients)

Exercise: Continue to Develop a Matrix for the Comparison of International GMPs. Add EU GMPs and Compare with U.S. Regulations and ICH Guidelines. Discuss and Highlight Significant Differences

VI. Comply with Japanese GMPs

• Examine the regulatory system in Japan
• Review and interpret the Japanese Ministry of Health, Labour and Welfare (MHLW) Ordinances
  • The Japanese GMP Regulations 1998
  • Regulations for manufacturing control and quality control of drugs; buildings and facilities; validation; investigational products and biological preparations; QA of imported drugs and medical devices; and other GMP regulations on cosmetics, medical devices, etc.
• Outline revisions to Japan's Pharmaceutical Affairs Law (PAL) that became effective as of April 2005
• Highlight Japan's transition to the adoption of ICH guidelines
  

Exercise: Complete a Matrix for the Comparison of International GMPs. Add Japan Regulations and Compare with U.S., EU and ICH. Discuss and Highlight Significant Differences

VII. Interactive Module – Apply Lessons to Hypothetical Example

• Review the matrix developed and completed earlier in the course
• Discuss and highlight significant differences among regions
• Evaluate a mock company's SOPs to determine whether the company is compliant with FDA GMPs, EU GMPs, Japanese GMPs, and ICH guidelines
• Highlight various approaches to international GMP compliance (e.g., meeting the strictest requirements) and discuss how to decide upon the right approach for your company, including how to weigh risk versus cost