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4 key points for a better understanding of ICH Q3D approach

Our experience with the implementation of ICH Q3D has showed that the new approach is not always well-understood by suppliers, probably due to the length and complexity of the guideline. This issue provokes a lot of time-consuming actions (hundreds of emails between customer-supplier, fulfilling questionnaires that are not enough for the drug product manufacturer, etc.).

In this post we aim to help understanding the ICH Q3D approach and ensure compliance in pharmaceutical raw materials through 4 key points:

  1. The ICH Q3D approach for limiting elemental impurities includes all potential sources: intentionally added elements and non-intentionally added elements require assessment.
    1. review of the manufacturing process (including raw materials) will determine the presence of intentionally added elements.
    2. There are certain elements that, due to their relatively high natural abundance and toxicity, are considered as potentially present even if not intentionally added. These elements require consideration always in the risk assessment.
  2. The ‘heavy metals test’ (monograph 2.4.8) has been deleted from the Eur. 9th Edition (only for veterinary products). The compliance must be done now with the General Chapter 5.20 and the monograph 2.4.20 (Determination of Elemental Impurities). Both references are based on the ICH Q3D.
  3. The presence/absence of the 24 elemental impurities included in the ICH Q3D may be determined by analytical testing and/or risk assessment (based on the expected administration route as determined in 1.b). Analytical testing should be performed with appropriate techniques (ICP-MS) in at least 3 representative industrial-scale batches. The Limit of Quantitation (LOQ) for each element should be indicated.
  4. The result of the risk assessment should be compared with the permitted limits of the ICH Q3D. This would determine if further actions (should as updating specifications) are required.

 

IN SUMMARY:

According to all mentioned considerations, a drug product manufacturer will need a document that includes at least:

 

  • Intentionally added elements: indicate which elements are intentionally added, expected/actual concentration, analytical method (with LOQ) and frequency of testing.
  • Non-intentionally added elements (min. Class 1 and 2A): indicate their expected concentration and expected/actual concentration, analytical method (with LOQ) and frequency of testing or number of representative batches tested.
  • Control of elemental impurities: indicate if there are any elemental impurities included in specifications and method of analysis (it should be validated).

 

Also, for an in depth review of ICH Q3D details, register for our next free webinar:

References:

[1] ICH Q3D (Guideline for Elemental Impurities) step 4

https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf

[2] Implementation of the ICH Q3D in the Certification Procedure

https://www.edqm.eu/sites/default/files/implementation_of_ich_q3d_in_the_certification_procedure_august_2016.pdf

[3] Ph.Eur. policy on elemental impurities

https://www.edqm.eu/sites/default/files/press_release_elemental_impurities_pheur_2015.pdf

 

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