With input from the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, the template provides a standardized format to collect information relative to Class 1, 2A, 2B and 3 elements in the ICH Q3D Step 2b proposed guideline.
Class 4 elements were not included since these were not considered by ICH Q3D to be a safety risk and no PDEs were established. Information on the excipient source is included as this can be a key factor in risk assessment, IPEC says.
“It is also important to stress that many excipient suppliers may not have information on the presence of many of the elements listed in ICH Q3D,” IPEC notes. Twenty four elements are listed in the template, including arsenic, cadmium, mercury, lead and cobalt.
IPEC hopes that through the request form and consolidation of the responses, both parties can begin to gain a better understanding of the potential elemental impurity levels for excipients used in drug products in preparation for the ICH Q3D Metal Impurities Guideline, which is currently a Step 2b document, as well as compendial requirements in USP General Chapter <232> Elemental Impurities Limits, which is expected to be aligned with the ICH Guideline when it’s finalized.
Both the Q3D document and the General Chapter offer similar formulas for calculating impurities, though the limits may end up being different, experts previously told us.
IPEC-Americas hopes the template will streamline the process of informing customers of potential impurities as the template can be used as an alternative to completing individual forms received from customers.
IPEC notes that the information companies will plug into the template is a key part of the pharmaceutical company's risk assessment process to determine their next steps to plan for eventual implementation of the final guideline's limits of these elements in the finished drug.
Information is also requested regarding the source or type of excipient since this can be an important factor in the assessment of potential metals, IPEC says, noting that an excipient may be a mineral or it can be mineral derived, i.e. a mineral that is further synthetically processed.
The coalition did not respond to a request for comment on how industry was responding to the release of these documents.