Manostaxx - Industrial Management Consulting
Manostaxx – Industrial Management Consulting


Elemental impurities in drug products may arise from several sources; they may be residual catalysts
that were added intentionally in synthesis or may be present as impurities (e.g., through interactions
with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits. There are three parts of this guideline: the evaluation of the toxicity data for potential elemental impurities; the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern; and application of a riskbased approach to control elemental impurities in drug products. An applicant is not expected to
tighten the limits based on process capability, provided that the elemental impurities in drug products
do not exceed the PDEs. The PDEs established in this guideline are considered to be protective of
public health for all patient populations. In some cases, lower levels of elemental impurities may be
warranted when levels below toxicity thresholds have been shown to have an impact on other quality
attributes of the drug product (e.g., element catalyzed degradation of drug substances). In addition, for
elements with high PDEs, other limits may have to be considered from a pharmaceutical quality
perspective and other guidelines should be consulted (e.g., ICH Q3A).

This guideline presents a process to assess and control elemental impurities in the drug product using
the principles of risk management as described in ICH Q9. This process provides a platform for
developing a risk-based control strategy to limit elemental impurities in the drug product.

The guideline applies to new finished drug products (as defined in ICH Q6A and Q6B) and new drug
products containing existing drug substances. The drug products containing purified proteins and
polypeptides (including proteins and polypeptides produced from recombinant or non-recombinant
origins), their derivatives, and products of which they are components (e.g., conjugates) are within the
scope of this guideline, as are drug products containing synthetically produced polypeptides,
polynucleotides, and oligosaccharides.

This guideline does not apply to herbal products, radiopharmaceuticals, vaccines, cell metabolites,
DNA products, allergenic extracts, cells, whole blood, cellular blood components or blood derivatives
including plasma and plasma derivatives, dialysate solutions not intended for systemic circulation, and
elements that are intentionally included in the drug product for therapeutic benefit. This guideline
does not apply to products based on genes (gene therapy), cells (cell therapy) and tissue (tissue
engineering). In some regions, these products are known as advanced therapy medicinal products.
This guideline does not apply to drug products used during clinical research stages of development.
As the commercial process is developed, the principles contained in this guideline can be useful in
evaluating elemental impurities that may be present in a new drug product.
Application of Q3D to existing products is not expected prior to 36 months after publication of the
guideline by ICH.

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