Impurities Workshop Part I: General Strategies for Identification and Control of Impurities - Live Online Training
Target Group
Objectives
- 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
- Approaches for investigation and determination of unexpected impurities
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 Sartan cases made clear the importance of a thorough process understanding.
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?
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 € 990
APIC Members € 1,090
Non-ECA Members € 1,190
EU GMP Inspectorates € 595
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
Costs
| ECA-Member*: | € 990,- |
| Regular Fee*: | € 1190,- |
| EU/GMP Inspectorates*: | € 595,- |
| APIC Member Discount*: | € 1090,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
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
Testimonials
