Pharmaceutical manufacturers are regularly required to carry out impurity control analysis on their batches in accordance with ICH Q3D.
objectifs
Training in the advanced analytical techniques required for ICH Q3D analysis, such as ICP (ICP-AES and ICP-MS)
Learn specific sample preparation methodologies and master an appropriate quality environment
Teaching methods
- Presentation of the training materials
- Distribution of the training materials
- Training led by experts in the requested techniques
Target audience
Technicians or engineers responsible for research & innovation, process & industrialization …
Program
For more information about the program, please contact us
Updated information on 27.03.2025
Practical information
- In-house training
- Questionnaire at the beginning and end of the training (quiz)
- Attendance sheet
- Duration: to be determined
- Accessibility for people with reduced mobility and persons with disabilities
- Adaptable according to the client’s needs
- Price on request
- No prerequisites required to take part in this service
- A certificate of completion will be issued to beneficiaries at the end of the training
Our training courses are accessible to people with disabilities. We will offer adapted solutions (for example: training materials, training pace, educational support, etc.) and adjustments according to your needs.
Your teams need training in the analysis of elemental impurities according to ICH Q3D
Why choose FILAB for training in the analysis of elemental impurities according to ICH Q3D?
As an approved training organization, FILAB supports your teams in learning how to implement elemental impurity analysis in pharmaceutical products according to ICH Q3D.
At FILAB laboratory, we develop and offer our clients only tailor-made training courses, aligned with your industrial challenges or analytical requirements.
Training on the ICH Q3D standard at FILAB laboratory ...
Have you just hired new talent in your laboratory? Are the qualified person or persons no longer part of your teams? Would you like to deepen your expertise in the ICH Q3D standard?
As an approved training organization, FILAB supports your teams with training on the ICH Q3D standard.
At FILAB, we develop and offer our clients only tailor-made training courses, aligned with your industrial challenges or analytical requirements.
Why call on FILAB for any training in analytical chemistry or materials science?
The FILAB laboratory is QUALIOPI certified for its training activities.
Thanks to this certification, the training courses we provide may be eligible for funding requests from OPCOs.
Analytical training is essential for professionals seeking to master analysis and characterization techniques; indeed, it covers a wide range of techniques intended for the analysis and characterization of substances, materials, or products in various industrial sectors.
Our analytical training programs are designed to equip participants with the skills needed to excel in their field, combining rigorous theory with practical applications. Discover how our analytical training can transform your skill set within your company.
Several reasons are behind the growing number of training requests to FILAB:
Tailor-made technical training: most of the training courses offered by many training organizations are standard, not tailored to your needs, and do not address your technical challenges
Highly qualified professionals: our trainers are laboratory staff, specialized PhD holders or engineers
Industrial expertise: FILAB has been providing training to its clients for over 10 years, regardless of the industrial sector
A unique profile with dual expertise in Chemistry and Materials
A human-sized organization, allowing us to provide greater responsiveness and flexibility
The ICH (International Conference on Harmonisation) Q3D guideline establishes the methodology to be followed for assessing elemental impurities in pharmaceutical products, including medicinal products for human use.
Thus, the ICH Q3D classifies elemental impurities into 4 classes, as follows:
- Class 1: elements toxic to the body that should not be used in the manufacture of medicines. The elements are as follows: Arsenic, Cadmium, Mercury and Lead.
- Class 2: elements considered toxic to humans, with a distinction regarding the importance of the route of administration concerned. Class 2 is itself subdivided into two classes, 2A and 2B, according to the probability of the EI being present in the medicine.
2A: There is a high probability that Class 2A impurities will be found in the medicine. Class 2A includes the following elements: Cobalt, Nickel and Vanadium.
2B: The probability of being present in the finished product is lower than for those belonging to Class 2A. Their toxicity is also lower.
The elemental impurities are as follows: Silver, Gold, Iridium, Osmium, Palladium, Platinum, Rhodium, Ruthenium, Selenium and Thallium. - Class 3: elemental impurities with low oral toxicity. Nevertheless, toxicity through other routes of administration remains a matter of concern.
The elemental impurities found in this category are as follows: Barium, Chromium, Copper, Lithium, Molybdenum, Antimony and Tin.
