Dr Gerd Jilge
Formerly Boehringer Ingelheim
Referent:innen
Dr Ulrich Rose
Straßburg
Dr Cornelia Nopitsch-Mai
formerly Quality Assessor
Dr. Reinhard Stidl
Safetree Consulting
Dr. Xaver Schratt
GBA Pharma
Dr. Andrew Teasdale
Astra Zeneca
Dr. Karel Haesevoets
Nelson Labs
All times mentioned are CET.
Dates / Technical Requirements / Presentations / Certificate
Dates
The Impurities Workshop Part I: General Strategies for Identification and Control of Impurities
18 November 2025, 08.30 – 17.15 h CET
The Impurities Workshop Part II: Nitrosamine Impurities
19 November 2025, 09.00 – 16.30 h CET
The Impurities Workshop Part III: Elemental Impurities
20 November 2025, 09.00 – 13.45 h CET
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Part I: General Strategies for Identification and Control of Impurities on 01 December
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 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: Selecting Analytical Procedures and Setting Acceptance Criteria of Impurities during Drug Substances Synthesis
- Purity analysis by HPLC, impurity profile
- Residual solvents by GC
- Inorganic impurities (heavy metals, sulphated ash)
- For chiral compounds in addition: enantiometric 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
Extractables and Leachables – What is expected from packaging Materials for Drug Products?
- Why should Extractables & Leachables be assessed?
- Regulatory requirements in the EU and US
- Compendial requirements and industry standards
- Safety qualification of Leachables and Extractables
How to avoid or address unexpected Impurities – Cleaning Procedures Pitfalls and particulate Matter Contamination
- 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?
Part II: Nitrosamine Impurities
European Pharmacopoeia Activities (Policy) on Mutagenic Impurities with Focus on Nitrosamines
- Ph. Eur. General policy on DNA reactive impurities
- Control of Nitrosamines in Ph. Eur.
- Changes in individual and general monographs following the Sartan case
- New general chapter on control of nitrosamines
Root Causes for Nitrosamine Impurities and other Mutagenic Impurities – Practical Approaches to Assess the Risks
- Development of a systematic risk based approach
- Key factors and the development of a decision tree
- API
- Drug Product
- Packaging
Safety Qualification of impurities - current Principles and Methods
- General approaches and regulatory framework for impurity qualification by safety threshold derivation
- Generic and substance specific safety thresholds
- Threshold of Toxicological Concern (TTC) - different scenarios
- Derivation of Permitted Daily Exposure (PDE) limits
- Acceptable exposure calculations based on TD50 and their limitations
- Approaches for data poor substances: (Q)SARs and read-across
- Route-to-route considerations for safety thresholds
- Analytical methods used for quantification of N-nitrosylated APIs in drug products
Case Study:
Conducting a Nitrosamine Risk Assessment - Evaluation through Case Studies
Conducting a Nitrosamine Risk Assessment - Evaluation through Case Studies
Several case studies will be presented and a risk assessment for different scenarios is shown taking into account e.g. manufacturing equipment, dosage form of the drug product, etc.
Nitrosamines and Other Genotoxic Impurities – Authorities' Expectations and Dossier Requirements- The assessor’s approach: principles of toxicological assessment
- Structural alerts
- Limits and Permitted Daily Exposure
- The ALARP principle
- Examples of low daily dose drug substances
- Impurities derived from alkylating agents (mesilate, besilate, tosilate, diisothionate); examples
- Nitrosamines – the Valsartan case
- Potential mutagenicc residual solvents
- Impurities derived from metal catalysts
Part III: Elemental Impurities
European Pharmacopoeia Activities (Policy) on Elemental Impurities – an Update
- Implementation of Q3D in Ph. Eur.
- Changes in individual and general monographs
- Harmonisation of general chapter 2.4.20
- Second phase for revision of excipient monographs
Control Strategies for Elemental Impurities in Final Dosage Forms – Case Studies
- Utilisation of Data as part of an Integrated EI Risk Assessment Process
- Potential Sources of Elemental Impurities in the Finished Product
- API
- Equipment
- Container-closure system
- Excipients
- Conclusions
Workshop: Conducting a Risk Assessment
In this Workshop the participants will work on several case studies and perform a risk assessment for different scenarios taking into account e.g. manufacturing equipment, dosage form of the drug product etc.
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1785,- |
| APIC Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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