Programme
- 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
- 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)
- 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
- 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
- Why should Extractables & Leachables be assessed?
- Regulatory requirements in the EU and US
- Compendial requirements and industry standards
- Safety qualification of Leachables and Extractables
- 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
- 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
- Development of a systematic risk based approach
- Key factors and the development of a decision tree
- API
- Drug Product
- Packaging
- 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
Conducting a Nitrosamine Risk Assessment - Evaluation through Case Studies
- 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
Further Information
Technical Requirements
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 events 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.
Fees (per delegate plus VAT)
ECA Members € 1,690
APIC Members € 1,740
Non-ECA Members € 1,890
EU GMP Inspectorates € 1,190
The conference fee is payable in advance after receipt of invoice
Presentations/Certificate
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.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Ms Anne Günster (Operations Director), +49(0)62 21 84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager), +49(0)62 21 84 44 25, bauer@concept-heidelberg.de
Date & Time
Tue, 27 October 2026, 8:30 – 17:15 h
Wed, 28 October 2026, 9:00 – 15:45 h
Costs
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 1190,- |
| APIC Member Discount*: | € 1790,- |
(All prices excl. VAT). Important notes on sales tax.
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This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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