Impurities Forum - Part I / Identification and Determination of Impurities

16 June 2015

Prague, Czech Republic

Course No 9258

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Speakers

Speaker from Authority
DR CORINA NACHTSHEIM, Quality Assessor, Germany
DR USFEYA A. MUAZZAM, Bonn, Germany

Industry Speakers
DR GISELA FONTAINE, Solvias AG, Switzerland
DR THOMAS HÄMMERLE, Baxter AG, Austria
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
DR HEIKE SCHMIDT-EISENLOHR, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR XAVER SCHRATT, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR LANCE SMALLSHAW, UCB Biopharma sprl, Belgium
DR ANDREW TEASDALE, Astrazeneca, United Kingdom
DR ANDREAS WOLF, AbbVie, Germany

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
Impurities qualification in biotechnology products

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.

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

The 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.

Programme

Part I: Identification and Determination of Impurities

Impurities in Context – The big picture and roadmap of the Impurities Forum
Impurities analysis in Drug Substances and Drug Products
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)

Analytical techniques for determination of impurities
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

Leachables and Extractables
Why should Extractables & Leachables be assessed?
Regulatory requirements of EMA and US-FDA
Compendial requirements and foodstuff regulations
PQRI and other recommendations for Safety Thresholds and Best Practices for
Extractables & Leachables testing

Impurity Qualification in Biotechnology Products
Process related impurities: Host cell DNA and host cell protein
Drug substance related impurities: Degradation products and ICH Guideline Q5C
Assay validation: Critical aspects
Process related impurities or contaminants: Endogenous retroviruses

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