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Q3D: Are your established products in compliance?

Here are ELC Group, we pride ourselves of providing our clients with the latest regulatory intelligence and tools for managing an ever-evolving regulatory landscape. One such example is compliance with the ICH guideline Q3D elemental impurities. The guideline was adopted by the CHMP in December 2014 and has come into effect for all new applications on June 2016. All existing approved authorisations must be in compliance by December 2017.

The Q3D guideline is intended "to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. Elemental impurities can be introduced – either intentionally or unintentionally – by excipients, manufacturing equipment, packaging (primary and secondary) and, of course, the drug substance itself. The ICH Q3D guideline identifies three key components to risk assess elemental impurities:

  1. Evaluation of toxicity data for potential elemental impurities.
  2. Establishment of Permitted Daily Exposure (PDE) values for each element.
  3. Development of controls for limiting inclusion of elemental impurities.

ICH notes that in some cases, a trade-off may be required, such as when manufacturing a product is impossible without introducing metal impurities, but such levels should still be noted.  The remainder of the guideline gets into the specifics of these impurities, including how to test for limits and which metals are known to be toxic to human health. The guideline breaks the various elemental impurities into four different classifications:

Class 1: (As, Cd, Hg and Pb): Highly toxic across all administration routes. These require special consideration during the risk assessment, due to their high toxicity and the potential for them to be present in finished dosage form through contributions of naturally derived materials.

Class 2: Toxic to a greater or lesser extent based on route of administration.

Class 3: Relatively low toxicity by oral route of administration, but require consideration in the risk assessment for other routes of administration.

Class 4: Elemental impurities that have been evaluated but for which a PDE has not been established due to their low inherent toxicity and/or regional regulations.

The guideline can be boiled down to four simple steps:

1. Identify:
Identify the sources of elemental impurities that are known or suspected, or have the potential to end up in the finished product.

2. Analyse:
Determine the probability of occurrence of the elemental impurities in the finished dosage form.

3. Evaluate:
Assess the actual or predicted levels of elemental impurities with the established PDEs.

4. Control:
Develop, document and implement a plan to limit the elemental impurities in the finished dosage form.

At ELC Group we can assist your company and deliver expert services in the following areas:

Determine the impact

In-depth assessment of your products and what levels of elemental impurities they contain, by considering all the potential sources of elemental impurities including:

  • Contributions from elemental impurities that are intentionally added to reactions or processes leading up to the preparation of the drug substance, reagents, starting materials or excipients (e.g. metal catalysts)
  • Those that are known or suspected to be present in the drug substance, reagents, water, starting materials or excipients used in the preparation of the drug product (e.g. lead present in a mined excipient)
  • Those that are known or suspected of being introduced into the drug substance or drug product from manufacturing equipment
  • Those that are known or suspected of being leached into the drug substance and drug product from container closure systems

Compliant documentation

Generate the required documentation to be kept on site and also any subsequent variations that need filing.

Proactive guidance

Follow up with regulatory submissions and discussions with authorities on compliance and specific guidance where needed.

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