EN

Your shopping cart

Amount

Total (VAT incl.)

VAT (21%)
Total
You have not added any reports to the cart yet.
Request reports
If you prefer to place your order via e-mail
contact us at: digital@azierta.com

Events and news

Blog
Home > Blog > Toxicology

What is ICH Q3D on elemental impurities?

Directive ICH Q3D aims to limit the presence of potentially toxic elemental impurities (also known as heavy metals) in pharmaceutical products intended for human use.

 

This directive is linked to changes in the pharmacopoeias (Ph.Eur. & USP) with the introduction of new, safer, more selective and precise analytical methods with greater reproducibility and better recovery.

 

Likewise the directive establishes the toxicity limits of potentially present elements.

 

Directive ICH Q3D sets out a list of 24 elements divided into four categories (classes 1, 2A, 2B and 3), in relation to their toxicity and their probability of occurrence and the maximum permitted daily exposure (PDE: Permitted Daily Exposure) for each impurity according to the administration route (µg / day).

Directive ICH Q3D sets out the methodology for:

 

  • The elements that must be taken into account.
  • The limits for each element.
  • The methodology to be followed in carrying out risk analyses.
  • Control strategies based on the values / limits obtained.

 

The implementation dates in Europe for this new regulation are:

 

Date Phase
December 2014 ICH Q3D Step 4
December 2014 Adopted by CHMP EMA/CHMP/ICH/353369/2013 (2)
June 2015 Pharmeuropa – Published list of pharmacopoeial monographs involved
June 2016 ICH Q3D applicable to new products
December 2017 ICH Q3D applicable to licensed products
In implementation phase Removal of references to monographs 2.4.8 on individual monographs

 

At Azierta, EUROTOX corporate members, we are experts in toxicology and ICH Q3D implementation. Our multidisciplinary team has AETOX, EUROTOX and ERT certified members. We design and develop customized action plans for the implementation of ICH Q3D of elemental impurities, with a background of more than 600 reports completed or in progress, both on a national and international basis, which have already been assessed by health authorities.

Visit our website and fill out our form to gain access to practical advice on the implementation of ICH Q3D on elemental impurities.

If you would like to know more about us, please visit: Elemental impurities risk analysis

Back

Related posts

What do you need for the cultivation of medicinal cannabis in...

What do you need for the cultivation of medicinal cannabis in Europe?

Read more

Azierta Webinar on the new requirements for Safety Data Sheets...

Azierta Webinar on the new requirements for Safety Data Sheets that will come into force on 1 January 2021

Read more

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

DO YOU HAVE ANY DOUBTS?

We help you in everything you need. Contact us by filling out the form or book an appointment for a video call with one of our experts.

We use "cookies" to improve your experience on our site. Cookies enable us to tailor messages and display ads to your interests. They also help us understand how our site is being used. By continuing to use our site you consent to use our cookies.

We are at your complete disposal for any inquiry

Thank you for getting in touch! We will contact you as soon as possible to help you out
There has been an error while submitting your form, please try again, or call us at 912 77 10 76