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Quality Assistance is ready for the onslaught of requests for the assessment of elemental impurities in substances used in the development and manufacture of new (and existing) medicinal products.

In less than 2 months, all new pharmaceutical products will have to comply with the ICH Q3D (International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use) – Guideline for Elemental Impurities published on 16 December 2014 – and in less than 2 years, it will be the case for all existing pharmaceutical products. At the centre of attention in the sector, ICH Q3D describes how to limit elemental impurities in pharmaceutical products, both qualitatively and quantitatively.

Quality Assistance developped validated methods!

Looking ahead to the countless samples which will have to be tested for elemental impurities, Quality Asisstance has developed two efficient, fast and ready-to-use generic methods that can be applied to active ingredients, finished products, excipients and containers. These two validated methods fulfil all the conditions for risk analysis as described in the ICH guideline.

The goal is to enable sponsors to avoid the high costs of development and validation of a specific method for each active ingredient, excipient or finished product.

The search for elemental impurities used to be limited to heavy metals, but increasing knowledge of the toxicity of other elements has resulted in a lengthening of the list which now contains 24 elements (e.g. : Arsenic, Mercury, Cadmium, Lead, Rhodium, Osmium,etc). As these impurities do not provide any therapeutic benefit to the patient, their levels have to be controlled so that they stay within acceptable limits.

A complete analytical service and state-of-the-art equipment

The Walloon CRO (Contract Research Organisation) provides a complete analytical service, combined with state-of-the-art equipment, for all types of files which need to comply with the ICH Q3D guideline:

  • cGMP certified environment
  • 5 ICP-MS systems
  • 2 ultrawave digestion systems
  • Special team of 5 highly qualified analysts
  • Service provided by experts in risk analyses, and in the definition and execution of control strategies

Quality Assistance CROQuality Assistance has been interested in the subject of elemental impurities since 2010, i.e. on the appearance of the first drafts of USP
chapters <232> and <233> in the Pharmacopeial Forum 36 and then of various editions of Q3D.

For almost 6 years, we've allocated resources to the development and validation of two generic methods which are efficient, rapid and ready-to-use.
Backed by over 30 years' experience in analytical services, the finalisation of this project means we can be recognised as experts in the field. We can provide you with validated, robust methods for rapid, efficient risk analyses and the development of control strategies“, explains Philippe De Raeve, Scientific Director of Quality Assistance and initiator of the research project.

Creation of a new dedicated entity

This new service for assessing elemental impurities has led to the creation of a ninth specialised entity in the company (situated in Donstiennes, Belgium). It should enable the SME to sustain the objectives set for 2016 i.e. to maintain double digit growth with a turnover of around 16.4 million euros… Elementary?!

About Quality Assistance

Quality Assistance is a benchmark European CRO, providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative medicinal products for human use.

Quality Assistance CRO
Quality Assistance CRO

Quality Assistance S.A.

Technoparc de Thudinie, 2
6536 Donstiennes

For more information contact:
Anne Manon
Corporate Communication Manager
+32 71 53 47 81 |

The post Elemental impurities: The pharmaceutical industry is up against the wall appeared first on Win Health | The health blog of Wallonia.