The Impurities Workshop - Part I and Part II
Im Auftrag der ECA Academy

The Impurities Workshop - Part I and Part II Im Auftrag der ECA Academy

Copenhagen, Denmark

Seminar Nr. 16405


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Speaker from Authority
DR ULRICH ROSE, Strasbourg, France

Industry Speakers
DR CHRISTOPHER DAY, AstraZeneca, United Kingdom
DR MANFRED FISCHER, Skyepharma (member of Vectura group), Muttenz, Switzerland
DR CRINA HEGHES, Lhasa Limited, United Kingdom
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
GRACE KOCKS, Lhasa Limited, United Kingdom
DR ANDREW TEASDALE, AstraZeneca, United Kingdom
DR LISE VANDERKELEN, Nelson Labs, Belgium


Impurities Workshop - Part I: General Strategies

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
  • Inorganic impurities
Practical aspects of method validation for impurity determination
  • Important ICH and FDA guidelines
  • Quantitation 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: Analytical techniques for determination and qualification of impurities in Starting Materials and Intermediates
  • Purity analysis by HPLC, impurity profile
  • Residual solvents by GC
  • Inorganic impurities (heavy metals, sulphated ash)
  • For chiral compounds in addition: enantiomeric purity and proof of the absolute configuration
In the Workshop, the participants will learn which activities are necessary to characterise drug substances taking into account the following aspects:
  • Analytical procedures are necessary for the characterisation
  • 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
Presentation and Workshop: 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

The Workshop will provide the opportunity to work on case studies about Leachables and Extractables regarding detection and safety qualification. It will seek, through a practical exercise, to examine the steps involved in a comprehensive E&L evaluation.

Impurities Workshop - Part II: Elemental Impurities and update on Mutagenic Impurities

Implementation of ICH Q3D in the European Pharmacopoeia
  • History of heavy metals tests
  • Implementation strategy of ICH Q3D in Ph. Eur.
  • Modifications of general chapters and general monographs
  • Specific metal tests in individual monographs
Analytical methods to determine metallic impurities
  • Principles and characteristics of the most common spectrometric techniques AAS, ICP-OES, ICP-MS
  • Compound methods (sample preparation plus spectrometric detection and quantification)
  • Special considerations for trace-elemental analysis
  • Application-based approach for choice of methodology
  • Analytical process (method development, validation strategy, routine testing)
Control Strategies for Elemental Impurities in final dosage forms – Case studies
  • Utilisation of Data as part of an Integrated EI Risk Assessment Process
  • Potential Sources of Elemental Impurities in the Finished Product: API, Equipment, Container-closure system, Excipients
  • Conclusions
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.

Reflections on ICH M7 – Recent developments and their impact / implications:
  • In silico predictions – overview of tools available / reflections on expert data review
  • Control options - Use of Purge calculations within control strategy
  • Compound specific limits – the ICH M7 addendum and beyond
  • Analysis of MIs – Key points from recent review article


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