Impurities Forum- Part I and Part II

Impurities Forum- Part I and Part II

Copenhagen, Denmark

Course No 15862


Costs

This conference already took place.

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Speakers from Authority & United States Pharmacopeia
Dr Ulrich Rose, EDQM, France
Dr Kahkashan Zaidi, USP, USA

Industry Speakers
Dr Gerd Jilge, Boehringer Ingelheim Pharma, Germany
Dr Samuel Powell, Pfizer, UK
Dr Xaver Schratt, LPU GmbH, Germany
Dr Andrew Teasdale, AstraZeneca, UK
Dr Lise Vanderkelen, Toxicon Europe, Belgium

Programme

Part I:
Impurities analysis and qualification 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
Control of organic impurities in the European Pharmacopoeia
  • Ph. Eur. analytical techniques used for impurity control
  • Impurity control in general chapters and monographs: General monograph 2034, General chapter 5.10 - control of impurities, General chapter 2.2.46 - chromatographic separation techniques
  • Qualitative and quantitative control: System suitability tests, Methods of quantification, Limit test vs quantitative test
  • Response and correction factors
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 puritymand 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
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
Stress stability testing during development
  • Elucidation of impurities of the drug substance
  • Identification of possible degradation products
  • Check of the degradation pathways
  • Typical experiments
  • Test parameter
  • Storage conditions
  • Stress tests of multi-use products
  • Impact on excipients and packaging materials

Part II.
EDQM’s implementation strategy of ICH Q3D in the European Pharmacopoeia – an update
  • 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
ICH Q3D on elemental impurities – requirements and implementation status in the USP general chapters and monographs

Analytical methods to determine elemental 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.

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