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45 - PHR - Pharmaceutical Sciences

PHR 105 - Control of Drug-related Impurities, Degradants and Potential Toxic Impurities in Drug Substance and Drug Product

Code Start Date Duration Venue
PHR 105 06 November 2023 5 Days Istanbul Registration Form Link
PHR 105 04 December 2023 5 Days Istanbul Registration Form Link
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Course Description

The control of drug-related impurities can be the source of much anxiety, including the establishment of specifications and during release and stability testing of subsequent samples. This course will help participants to understand the expectations, and give practical advice for setting specifications and for addressing issues during routine testing.

Course Objectives

  • Understanding what specifications will conform to regulatory expectations
  • Developing an process for reporting impurities and addressing OOS situations
  • Understanding regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals

Who Should Attend?

  • Chemists
  • Supervisors
  • Laboratory Managers (Research, Quality Control, CRO)
  • Quality Assurance personnel involved with generating reporting impurity results
  • Regulatory affairs/CMC personnel responsible for documenting compliance with impurity requirements.

Course Details/Schedule

Day 1

  • Landscape of impurities requiring control in pharmaceutical products
  • General impurities: elemental impurities, residual solvents, microbiological
  • Drug-related impurities: process impurities, degradants, potentially genotoxic impurities

Day 2

  • Process Impurities
  • Understanding ICH Q3A
  • Where impurities originate
  • How impurities are characterized

Day 3

  • How specifications are developed
  • How impurities should be reported

Day 4

  • Degradants
  • Understanding ICH Q3B
  • Where degradants originate
  • How degradants are characterized

Day 5

  • Potential genotoxic impurities
  • How specifications are developed
  • How degradants should be reported