Impurities Forum- Part I: General Strategies

27 June 2017

Copenhagen, Denmark

Seminar Nr. 15861

Unser Seminarservice

Kosten

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

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

Objectives

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
Stress stability testing as a tool to determine degradation pathways

During this event you will get to know the relevant aspects of impurities analysis, characterisation and control in drug substances and drug products and their recording and reporting.

Background

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.

Target Group

This workshop 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

Programme

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

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