Elemental Impurities Regulations - View from a CRO

Regulatory control of elemental impurities in pharmaceutical products has long been discussed, with both the European Pharmacopeia (EP) and the United States Pharmacopeia (USP) having planned on issuing specific chapters relating to contamination from elemental substances. New regulations have been postponed several times, most recently to take into consideration the guidance from The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). With this document now in place the relevant pharmacopeias are almost certainly finalised as to their respective approaches to the implementation of these regulations.

What is the impact on pharmaceutical companies? The changes to the pharmacopeias have meant that a simple general wet chemistry test for assessing elemental contamination has been replaced with a requirement to assess a risk of likelihood of contamination and use of spectroscopic techniques to quantify the level of contaminants in drug products if a potential risk is identified.

With emphasis on the use of spectroscopic techniques such as Inductively Coupled Plasma – Mass Spectrometry (ICPMS) and Inductively Coupled Plasma – Optical Emission Spectrometry (ICP-OES), this will mean that there is a greater requirement for validation of these techniques for specific materials.

Contract Research Organisations (CRO’s) can provide a valuable support role to pharmaceutical companies to assist in their analytical needs, from development projects, through to QC and batch release, due diligence and safety testing, often to ensure raw materials and products conform to regulatory obligations set out in the pharmacopoeias.

In this white paper, an overview will be given on how the regulations have evolved through the pharmacopeias, how the ICH has impacted these regulations, how these could be implemented by manufacturers and the role of CROs in this process.

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