Elemental Impurities Risk Assessments

Guaranteed quality and regulatory compliance
through professional risk analyses in accordance with ICH Q3D.

The ICH Q3D guideline (EMA/CHMP/ICH/353369/2013) aims to limit and control the presence of elemental impurities ("heavy metals") in medicinal products in order to ensure their quality and safety. This requires a risk analysis using an end product or component approach (EMA/CHMP/QWP/115498/2017).

Our cooperation partners carry out the ICH Q3D risk assessment of elemental impurities for each product based on the proposed approaches and evaluate the best possible option depending on the type of product, the available information and customer requirements.

Each risk assessment is prepared in English by ERT- or DABT-certified toxicologists.

The risk assessment of elemental impurities should be based on the following points:

Identification

Identify all possible sources of contamination (active ingredients, excipients, manufacturing process, water or primary packaging).

Analysis

Analyse the elemental impurities that may be present in the product.

Assessment

Assess the values of the elemental impurities and compare them with the specified limit values.

Specification

Establish strategies for controlling contamination levels to ensure that limits are not exceeded..

This is what we need from you to prepare an Elemental Impurities Risk Assessment according to ICH Q3D:

Name and address of the company
Name of the medicinal product

Our customers are saying:

... many thanks for the professional support in this matter"

"... summarised very nicely "

"... we will be happy to come back to you in comparable situations "

"... worked out perfectly "

"... we appreciate the constructive collaboration with the colleagues from Azierta very much "

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PDE Report

OEL Report

Elemental Impurities Risk Assessment

Organic Impurities

Mutagenic Impurities

Environmental Risk Assessment (ERA)

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Cynthia Schulz

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Elemental Impurities Risk Assessment | Sample Document

Why do you need an elemental impurities risk assessment? As of June 2016, all new medicinal products have to be evaluated based on the ICH guideline Q3D on elemental impurities. As of December 2017, this guideline came into effect for already authorised medicinal products as well. Therefore, every authorised medicinal product has to be evaluated. How to obtain an elemental impurities risk assessment? The proven and successful collaboration between Azierta and GMP-Verlag Peither AG provides you with an economically priced alternative to conventional elemental impurities risk assessments. Following verification of the critical key data, we will be pleased to send you a binding, fixed price quote. Our service includes Issuing of the elemental impurities risk assessment According to ICH Q3D guideline in English Issued for the specific medicinal product according to ICH Q3D guideline Issued by European toxicological experts This is what we need from you to prepare a binding, fixed price quote Company name and address Name of the medicinal product

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How to implement ICH Q3D of elemental impurities in 5 steps (free manual)

Why do you need an elemental impurities risk assessment?As of June 2016, all new medicinal products have to be evaluated based on the ICH guideline Q3D on elemental impurities. As of December 2017, this guideline came into effect for already authorised medicinal products as well. Therefore, every authorised medicinal product has to be evaluated.How to obtain an elemental impurities risk assessment? The proven and successful collaboration between Azierta and GMP-Verlag Peither AG provides you with an economically priced alternative to conventional elemental impurities risk assessments. Following verification of the critical key data, we will be pleased to send you a binding, fixed price quote. Our service includes: Issuing of the elemental impurities risk assessment according to ICH Q3D guideline in English issued for the specific medicinal product according to ICH Q3D guideline issued by European toxicological experts This is what we need from you to prepare a binding, fixed price quote Company name and address Name of the medicinal product Completed questionnaire

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€0.00 net excl. VAT

Details