The Impurities Forum Part I - Live Online Training

Thursday, 9 November 2023 8 .30 - 17.00 h

Course No. 20648

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Speakers

Dr. Xaver Schratt

Dr. Xaver Schratt

GBA Pharma

Dr. Gerd Jilge

Dr. Gerd Jilge

Formerly Boehringer Ingelheim,

Dr. Ulrich Rose

Dr. Ulrich Rose

Straßburg

All times mentioned are CET

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
  • Important monographs and chapters in Ph. Eur. for control of impurities 
  • Practical aspects of method validation for impurities Determination
  • Analytical techniques used for detecting and qualifying impurities
  • Extractables and Leachables as a source of impurities
  • Approaches for investigation and determination of unexpected impurities
This Live Online Training 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. The Valsartan case made clear the importance of a thorough process understanding.

Target Group

The Live Online Training 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 Live Online Training will also address regulatory requirements and hence is applicable to people working in the Regulatory Affairs area.

Technical Requirements

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Programme

The Impurities Forum Part I - Live Online Training

Seminar Programme as PDF

Part 1
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
Control of Impurities in Ph.Eur.
  • Which impurities are controlled?
  • General texts/monographs/ICH Guidelines
  • Organic impurities in Ph. Eur.
  • Specification Setting
  • Validation
  • Elemental impurities
Analytical Method Validation for Impurities
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
Applying an example of an API synthesis the participants will learn in the Workshop 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
Extractables and Leachables – What is Expected from Packaging Materials for Drug Products?
  • Why should Extractables & Leachables be assessed?
  • Regulatory requirements and guidelines in the EU and US and pitfalls
  • General flow and critical aspects of Extractables & Leachables  studies
  • Safety qualification of Extractables and Leachables
How to Avoid Unexpected Impurities: Approaches to Establish a Holistic Understanding of Impurity Risks
  • 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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This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

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