Active Pharmaceutical Ingredient (API) & Drug Product Specifications – From Clinical Development to Market Approval™


First Day

Why Product Specifications Are Necessary

  • Terminology defined: specification, acceptance criteria, in-process vs release vs shelf life, parametric release, periodic/skip testing, real-time release testing (RTRT)
  • Acceptance criteria vs action limits
  • Strengths, and limitations, of specifications as an effective control system – could mean life or death for a patient

Regulations and Guidances on Product Specifications

  • Regulatory specification requirements – FDA and EMA
  • ICH Q and pharma industry specification setting guidances – similarities and differences between chemical drugs and biologics
  • Handling out-of-specification (OOS) test results

Clinical Phase-Appropriate Specification Assignment

  • Preliminary specifications for early stage clinical development
  • Updated/refined specifications for later stage clinical development
  • Patient safety specifications at market approval level even during clinical development

Required API and Drug Product Specifications 

  • Proper foundation for specification assignments
  • Similarities and differences between chemical drugs and biologics in release specifications needed
  • Challenge of regional specifications for a global company

Second Day

Quality by Design (QbD) Applied to Specifications

  • Setting up an effective Specification Committee
  • Strategic ICH guidances: Q8, Q9, Q10
  • Quality by Design (QbD) applied to specification setting – balancing patient safety concerns with manufacturing process performance and regulatory authority expectations

Statistical Approaches to Establishing Specifications:

  • Understanding of basic statistics - mandatory
  • Case examples of establishing patient safety regulatory specifications
  • Case examples of establishing manufacturing process consistency specifications

Preparing CTD Regulatory Submissions on Product Specifications

  • Specifications in Module 2.3 Quality Overall Summary and Module 3 Quality
  • Justification of inclusion and/or exclusion of product specifications
  • Interim regulatory specifications – post-market approval commitments – specification lifecycle

Managing Regulatory Authority Specification Interactions/Inspections

  • Regulatory report card on pharmaceutical specification assignments
  • Case examples of problems with proposed regulatory specifications
  • Inspector interest in assigned specifications – what they want to see and why


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