Pharmaceutical manufacturers are regularly asked to carry out impurity control analyses on their batches in accordance with ICH Q3D.
objectives
Training in state-of-the-art analytical techniques required for ICH Q3D analysis, such as ICP (ICP-AES and ICP-MS)
Apprendre les méthodologies de préparation d'échantillons spécifiques, et à maîtriser un environnement qualité adéquate
Learning resources
- Projection of training material
- Handover of training material
- Training led by experts in the techniques required
Audience
Technicians or engineers in charge of research & innovation, process & industrialization …
Program
For more information on the program, please contact us
Information updated on 27.03.2025
Practical information
- In-company training
- Questionnaire at the beginning and end of the course (Quizzes)
- Attendance sheet
- Duration: to be determined
- PRM and PSH accessibility
- Adaptable to customer needs
- Price on quotation
- No pre-requisites required for this course
- A certificate of completion will be issued at the end of the course.
Our training courses are accessible to people with disabilities. We will offer you solutions for adaptations (e.g. training aids, pace of training, teaching support, etc.) and adjustments to suit your needs.
Your teams need training in analysis of elemental impurities according to ICH Q3D
Why choose FILAB for training in ICH Q3D elemental impurity analysis?
As an accredited training organization, FILAB supports your teams in learning how to implement ICH Q3D analysis of elemental impurities in pharmaceutical products.
At the FILAB laboratory, we develop and offer our customers tailor-made training courses, in line with your industrial issues or analytical challenges.
The FILAB laboratory's ICH Q3D training ...
You have just recruited new talent for your laboratory? Are the right person(s) no longer part of your team? Would you like to perfect your expertise in the ICH Q3D standard?
As an accredited training organization, FILAB can provide your teams with ICH Q3D training.
At FILAB, we only develop and offer our customers tailor-made training courses, in line with your industrial issues or analytical challenges.
The ICH (International Conference on Harmonisation) Q3D guideline establishes the methodology to be followed for the evaluation of elemental impurities in pharmaceutical products, including human drugs.
Thus, the ICH Q3D classifies elemental impurities into 4 classes, as follows
- Class 1: Elements that are toxic to the body and should not be used in the manufacture of drugs. The elements are as follows: Arsenic, Cadmium, Mercury and Lead.
- Class 2: Elements considered to be toxic to humans, but with a nuance as to the importance of the route of administration considered. Class 2 is itself subdivided into two classes, 2A and 2B, according to the probability of presence of the EI in the drug.
2A: There is a high probability of Class 2A impurities being present in the drug. Class 2A includes the following: Cobalt, Nickel, and Vanadium.
2B: The probability of presence in the finished product is less than those belonging to class 2A. Their toxicity is also less.
The elemental impurities are the following: Silver, Gold, Iridium, Osmium, Palladium, Platinum, Rhodium, Ruthenium, Selenium and Thallium.
- Class 3: elemental impurities with low oral toxicity. Nevertheless, the toxicity for other routes of administration remains a concern.
The elemental impurities found in this category are the following: Barium, Chromium, Copper, Lithium, Molybdenum, Antimony and Tin.
The ICH Q3D guideline has been applicable since June 2016 for new Marketing Authorization Applications (MA), and in January 2018 for drugs already on the market.
Pharmaceutical manufacturers are regularly required to perform impurity control analysis on their batches according to ICH Q3D.
However, ICH Q3D requires advanced analytical techniques such as ICP (ICP-AES and ICP-MS). It is also necessary to follow specific sample preparation methodologies, and an adequate quality environment.
Also, the support of a specialized laboratory, through a customized training of your teams, can be an asset in your activities.
