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DR CORINA NACHTSHEIM, Quality Assessor, Germany
DR GISELA FONTAINE, Solvias AG, Switzerland
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
DR SAMUEL POWELL, Pfizer, United Kingdom
DR ULRICH ROSE, Strasbourg, France
DR XAVER SCHRATT, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR ANDREW TEASDALE, AstraZeneca, United Kingdom
Part I of the Impurities Workshop 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
Impurities qualification – examination of approaches based on duration
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.g.
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.
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 aread.
Analysis and qualification of Impurities in Drug Substances and Drug Products – general overview
Impurity profiling in synthetic drug substances
Qualification of impurities
Identification of chiral impurities, polymorphic phases and new impurities
Impurities in starting materials and intermediates
Pharmacopoeial tests and acceptance criteria
Drug product specifications and parametric release
Practical aspects of method validation for impurity determination
Important ICH and FDA guidelines
Quantitation of impurities
How to define an impurity profile (stress tests)
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.