Impurities Forum 2019 - Part I - General Strategies for Investigation and Control
Im Auftrag der ECA Academy

26 June 2019

Praha, Czech Republic

Seminar Nr. 16955

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Kosten

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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Dr Xaver Schratt, GBA Pharma GmbH, Germany
DR ANDREW TEASDALE, AstraZeneca, United Kingdom
DR LISE VANDERKELEN, Nelson Labs, Belgium

Zielsetzung

Part I of the Impurities Forum will provide an opportunity to reinforce and expand your knowledge of the general area of impurities in chemical entities from initial development to the market with emphasis on

Detection, profiling and control of impurities in drug substances, intermediates and drug products
Practical aspects of method validation for impurities Determination
Analytical techniques used for detecting and qualifying impurities
Extractables and Leachables as a source of impurities
“Unexpected Impurities” – lessons learned from the Valsartan case

This event is designed to provide a comprehensive review of impurities analysis and characterisation in drug substances and drug products and their recording and reporting.

Hintergrund

Setting specifications for impurities are one of the most critical topics in the development of new drug products. Impurities analysis in drug substances and drug products and their recording and reporting is quite often a challenge for the scientific experts in routine production and quality control.

This challenge is even bigger when profiles of unknown impurities in complex matrices have to be established. The recent Valsartan case made clear the importance of a thorough process understanding.

Zielgruppe

This conference addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered. This event will also address regulatory requirements and hence is applicable to people working in the regulatory affairs area.

Programm

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 Impurity 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:
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 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

The subsequent plenary workshop will provide the opportunity to discuss 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.

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?

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Impurities Forum 2019 - Part I - General Strategies for Investigation and ControlIm Auftrag der ECA Academy