PTI - international

I. Introduction to cGMPs for Manufacturing Clinical Supplies

• Outline course objectives
• Define common acronyms
• Identify clinical supply activities
• Examine cGMPs and how they affect clinical supply manufacturing
• Contrast clinical supply manufacture and commercial manufacture

Discussion: Review Participants' Backgrounds and Experiences

II. Analyze Current GMPs

• Outline the history of the FDA's GMP regulations
• Comply with cGMP regulations and guidelines for clinical trial supplies
• Examine EU GMP guidelines for clinical trial supplies

Exercise: Propose/Select Dosage and Delivery Systems for Hypothetical NCE, Phase I Study

Exercise: Determine the Differences Between Clinical Supply and Commercial Manufacturing

III. Define the Roles and Responsibilities of Clinical Supply Personnel

• Determine roles and responsibilities of:
  • QA/QC unit
  • Clinical production
  • Regulatory professionals
  • Suppliers/Vendors/Contractors

IV. Comply with GMP Requirements for Facility/Utility Design

• Specify building requirements
• Maintain HVAC and water systems
• Determine IQ/OQ/PQ of manufacturing equipment
• Define validation and qualification

V. Prepare for Manufacturing Clinical Supplies

• Examine key concepts that facilitate planning clinical supply projects
• Implement techniques to streamline clinical supply processes
• Establish compliant protocols and process plans

Exercise: Prepare for Manufacture of Phase I Clinical Supplies

Exercise: Prepare for Manufacture of a Unique Phase I/II Clinical Dosage Form