PTI - international

Agenda: Day One

• Define SUPAC, associated terms and acronyms
• Identify the purpose of SUPAC implementation
• Clarify types or classifications of changes
• Describe industry perspective on the impact of regulatory expectations

Discussion: Review Participants' Experiences with SUPAC

II. Examine FDA 21 CFR 314.70

• Interpret current FDA expectations regarding 21 CFR 314.70 and anticipate future changes
• Clarify FDA actions for failure to comply with SUPAC guidelines
• Examine cGMP compliance issues with regard to the facilities/establishments involved in the changes to an approved application

III. Analyze FDA 21 CFR 314.70 and Supplements for Your Product

• Identify the purpose of the following:
  • CFR 314.70 (a) - Changes to an approved application
  • CFR 314.70 (b) - Supplements requiring FDA approval prior to changes
  • CFR 314.70 (c) - Supplements for changes made before FDA approval
  • CFR 314.70 (d) - Changes described in the annual report

IV. Assess the Impact of SUPAC on Your Product

• Differentiate all the SUPAC guidance documents
  • IR - Immediate Release
  • MR - Modified Release
  • SS - Semisolids
  • BACPAC - Bulk Actives Post-Approval Changes
  • IR/MR - Manufacturing Equipment Addendum
  • PAC-ATLS - Analytical Testing Laboratory Sites
• Critique change control system and its relevance to SUPAC

Exercise: Analyze Accepted Products with Post-Approval Changes

V. Critique SUPAC-IR for Compliance Integrity

• Describe the purpose of SUPAC-IR
• Explain immediate release solid oral dosage forms
• Critique documentation of post-approval changes in chemistry manufacturing and controls
• Identify procedures and importance of In Vitro Dissolution Testing In Vivo Bioequivalence Documentation

Exercise: Case Study Focusing on Correct/Incorrect Implementation of SUPAC-IR

VI. Analyze SUPAC-MR for Compliance Integrity

• Describe the purpose of SUPAC-MR
• Explain modified-release solid oral dosage forms
• Critique documentation of post-approval changes in chemistry manufacturing and controls
• Identify procedures and importance of In Vitro Dissolution Testing In Vivo Bioequivalence Documentation

Exercise: Case Study Focusing on Correct/Incorrect Implementation of SUPAC-MR

VII. Critique SUPAC-SS for Compliance Integrity

• Describe the purpose of SUPAC-SS
• Explain non-sterile semisolid dosage forms
• Critique documentation of post-approval changes in chemistry manufacturing and controls
• Identify procedures and importance of In Vitro Dissolution Testing In Vivo Bioequivalence Documentation

Exercise: Case Study Focusing on Correct/Incorrect Implementation of SUPAC-SS