The Impurities Workshop Part I and II - Live Online Training

18/19 October 2022

Course No. 20037

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Speakers

Dr. Ulrich Rose

Dr. Ulrich Rose

Straßburg

Dr. Xaver Schratt

Dr. Xaver Schratt

GBA Pharma

Dr. Cornelia Nopitsch-Mai

Dr. Cornelia Nopitsch-Mai

formerly Quality Assessor

Dr. Gerd Jilge

Dr. Gerd Jilge

Formerly Boehringer Ingelheim

All times mentioned are CEST.

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Programme

The Impurities Workshop Part I and II - Live Online Training

Seminar Programme as PDF

Part I: General Strategies for Identification and Control of Impurities
 
Analysis and Qualification of Impurities in Drug Substances and Drug Products – General Overview
  • Impurity profiling in synthetic drug substances
  • Qualification of impurities
  • Degradation studies
  • Identification of chiral impurities, polymorphic phases and new impurities
  • Residual solvents
  • Impurities in starting materials and intermediates
  • Pharmacopoeial tests and acceptance criteria
  • Drug product specifications and parametric release
Analytical Method Validation for Impurities
  • Determination at Various Development Stages
  • Quantification of impurities
  • How to define an impurity profile (stress tests)
  • Reference substances
  • Validation of methods at various development stages
  • Statistical approaches to method validation (LOD & LOQ)
Presentation and Workshop: Selecting Analytical Procedures and Setting Acceptance Criteria of Impurities during Drug Substances Synthesis
  • Purity analysis by HPLC, impurity profile
  • Residual solvents by GC
  • Inorganic impurities (heavy metals, sulphated ash)
  • For chiral compounds in addition: enantiometric purity and proof of the absolute configuration
In the Workshop the participants will learn which activities are necessary to characterize drug substances taking into account the following aspects:
  • Analytical procedures are necessary for the characterization
  • Experiments necessary to check the downstream impurities in order to justify acceptance criteria for the respective impurities
  • Other impurities have to be taken into account
  • Experiments to be performed in order to get a stability-indicating analytical procedure
Leachables and Extractables
  •  Why should Extractables & Leachables be assessed?
  •  Regulatory requirements in the EU and US
  •  Compendial requirements and  industry standards
  •  Safety qualification of Leachables and Extractables
Unexpected Impurities: Approaches for Investigation and Determination
  • Is there such a thing as ‘unexpected impurities” or is there a lack of process understanding?
  • Valsartan – overview of events
  • Source of contamination
  • Mechanistic understanding
  • Examination of risk within other Sartans – overview of how to conduct a risk assessment and to identify key factors
  • Are there other Mutagenic Impurities related risks?
Part II: Nitrosamine Impurities
 
European Pharmacopoeia Activities (Policy) on Mutagenic Impurities with Focus on Nitrosamines
  •  Ph. Eur. General policy on DNA reactive impurities
  •  Control of Nitrosamines in Ph. Eur.
  •  Changes in individual and general monographs following the Sartan case
  •  New general chapter on control of nitrosamines
Root Causes for Nitrosamine Impurities and Other Mutagenic Impurities – Practical Approaches to Assess the Risks
  •  Development of a systematic risk based approach
  •  Key factors and the development of a decision tree
    •  API
    •  Drug Product
    •  Packaging
ICH M7 Safety Risk Assessment and the Cohort of Concern – How to Deal with e.g. Nitrosamines
  •  Principles of cancer risk estimation in ICH M7
  •  Why was the cohort of concern excluded from ICH M7?
  •  Applicability to use ICH M7 based cancer risk assessment to the cohort of concern
  •  Nitrosamines, why are they in the cohort of concern?
  •  Major risk factors for sources of nitrosamines in drugs
  •  Way forward to handle cohort of concern within ICH M7
Workshop:
Conducting a Risk Assessment
In this Workshop the participants will work on several case studies and perform a risk assessment for different scenarios taking into account e.g. manufacturing equipment, dosage form of the drug product etc.

Nitrosamines and Other Genotoxic Impurities – Authorities' Expectations and Dossier Requirements
  •  The assessor’s approach: principles of toxicological assessment
  •  Structural alerts
  •  Limits and Permitted Daily Exposure
  •  The ALARP principle
  •  Examples of low daily dose drug substances
  •  Impurities derived from alkylating agents (mesilate, besilate, tosilate, diisothionate); examples
  •  Nitrosamines – the Valsartan case
  •  Potential mutagenicc residual solvents
  •  Impurities derived from metal catalysts

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This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

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