ICHQ3D implementation involves a risk analysis to design strategies to control elemental impurities in drugs for human use, accountability for which lies fully with the owners of the marketing authorisation. The deadline to implement this guideline for elemental impurities expires at the end of 2017.
In this interview, Paulino Alonso, Azierta’s Toxicology team responsible for ICHQ3D projects, share his impressions regarding key aspects related to the guideline.
Tell us about the background to this guideline?
Paulino Alonso: traditionally, when it comes to tackling the issue of elemental impurities, the heavy metals was the reference test, it was based on colorimetric detection, which was non-specific and applies not fully objective criteria. The ICH put forward much more specific guidelines that involve conducting detailed risk analysis and assessing the impurities on a case-by-case basis.
What are the main implications of the guideline?
Paulino Alonso: Basically it involves controlling the presence of impurities under a new concept, no longer using the same method for all drugs and changing to a strategy that studies the real risk, considering aspects such as the characteristics of the drug, the production process, the excipients, the amount of excipients, etc. Accountability for this principally lies with the owner of the marketing authorisation, who is ultimately responsible for the risk analysis.
Can you briefly tell us about the process involved when it comes to implementing these risk analyses?
Paulino Alonso: It is a four-step process:
- First, possible sources of contamination must be identified for each one of the products.
- Second, information must be gathered from the active pharmaceutical ingredient and excipient suppliers to identify the origin of these raw materials.
- After gathering these information, we then document the risk of each one of the possible sources of contamination, eventually passing on to assessing it.
- Lastly, the control measures are designed as it must be assured that the levels exposed in the analysis of the risks are going to hold up in time.
This is a complex process in which several alternatives can be used. In your experience, what are the basic criteria involved in selecting a particular strategy over another?
Paulino Alonso: It is difficult to give a straightforward answer given that there are many factors at play. All the options have their pros and cons. In our case we focus on the particular needs of each client with a view to assuring a good result within an optimum time and cost framework.
What aspects would you highlight as being key factors in implementing these processes?
Paulino Alonso: I would emphasise three in particular: having a comprehensive knowledge of the guideline and implementation alternatives, the contact with suppliers and a proper project coordination
What does Azierta offer as regards the implementation of this guideline?
Paulino Alonso: Experience in over 600 reports both for products in the development phase as well as already marketed products for both national and international companies; integrated project management; good agreements at analysis level; an elemental impurity database containing over 1,500 excipients and APIs, training to explain the implications of the guideline, as well as the reasoning behind each one of the reports, and lastly, albeit no less important for that, a good price.
To gain access to practical advice on the implementation of ICH Q3D on elemental impurities register here: https://azierta.eu/webinarichq3d/
At Azierta, we are experts in toxicology and EUROTOX corporate members. Our multidisciplinary team has AETOX, EUROTOX and ERT certified members.
If you would like to know more about us, please visit: https://azierta.eu/toxicological-experts/?lang=en