The Impurities Workshop Part I: General Strategies for Identification and Control of Impurities 18 November 2025, 08.30 – 17.15 h CET
The Impurities Workshop Part II: Nitrosamine Impurities 19 November 2025, 09.00 – 16.30 h CET
The Impurities Workshop Part III: Elemental Impurities 20 November 2025, 09.00 – 13.45 h CET
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Programme
Part I: General Strategies for Identification and Control of Impurities on 01 December
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
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
Extractables and Leachables – What is expected from packaging Materials for Drug Products?
Why should Extractables & Leachables be assessed?
Regulatory requirements in the EU and US
Compendial requirements and industry standards
Safety qualification of Leachables and Extractables
How to avoid or address unexpected Impurities – Cleaning Procedures Pitfalls and particulate Matter Contamination
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
Safety Qualification of impurities - current Principles and Methods
General approaches and regulatory framework for impurity qualification by safety threshold derivation
Generic and substance specific safety thresholds
Threshold of Toxicological Concern (TTC) - different scenarios
Derivation of Permitted Daily Exposure (PDE) limits
Acceptable exposure calculations based on TD50 and their limitations
Approaches for data poor substances: (Q)SARs and read-across
Route-to-route considerations for safety thresholds
Analytical methods used for quantification of N-nitrosylated APIs in drug products
Case Study: Conducting a Nitrosamine Risk Assessment - Evaluation through Case Studies
Several case studies will be presented and a risk assessment for different scenarios is shown 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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