Understanding International Biopharmaceutical CGMPs

• Understand the structure and function of international regulatory agencies:
  • EU: European Medicines Agency (EMA); Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S)
  • UK: Medicines and Healthcare products Regulatory Agency (MHRA)
  • Japan: Ministry of Health, Labour and Welfare (MHLW)
  • Canada: Health Products and Food Branch (HPFB)
  • Japan Pharmaceutical Manufacturers Association (JPMA)
  • International Conference on Harmonisation (ICH)
  • Australia: Therapeutic Goods Administration (TGA)
• Compare U.S. FDA CGMPs with those of EU, Japan, and Canada.
• Describe challenges related to variations among regulations across regions.
• Discuss recent efforts to harmonize GMP requirements through the development of mutual recognition agreements (MRAs) and the ICH, and the mutual development and implementation of its guidelines.
• Understand the benefits and challenges of regional CGMP requirements and guidelines in creating modern and robust quality systems.
• Discuss methods and tips to take into account international drug regulations applicable to your organization.

• Key international CGMP documents: FDA CGMPs, EU Annexes, PIC guidelines
• Canadian pharmaceutical CGMP requirements and HPFB interpretation of CGMP guidelines
• Harmonization efforts through ISO, WHO, and ICH initiatives
• Mutual recognition agreements: EU and Japan, EU and Canada (PIC/S)
• ICH guidelines:
  • Q7A – GMP Guide for Active Pharmaceutical Ingredients (APIs)
  • Q8 – Pharmaceutical Development
  • Q9 – Quality Risk Management
  • Q10 – Pharmaceutical Quality Systems
  • Others
• Impact of global harmonization efforts and international drug regulations on domestic biopharmaceutical manufacturers

This is an advanced course designed for QA and QC managers and personnel; validation specialists; regulatory affairs, training, and documentation departments; and consultants working for organizations manufacturing pharmaceutical and biotechnology drug products that are regulated by multiple agencies.