Specifications

• Specification development & stability assessment


  Setting critical parameters
• General consideration


  • Efficacy
  • Safety
• Components


  • Bulk drug
  • Excipients
  • Products
• QA of analytical measurements


  • System suitability tests
  • Laboratory analytical data QA - foundations
• Role of scientific & regulatory studies

  • Chemical degradation
  • Implications for specification setting
  • Relationship of expiration dating to label storage temperatures
  • Stability study design
  • Specialized stability studies
• Specialized stability studies


  • Photostability
  • Reconstituted stability
  • Container stability