Drugmakers ‘premature’ in requests for metal impurity data
pharmafile | April 5, 2012 | News story | Manufacturing and Production | ICH, manufacturing, metal impurity
Pharmaceutical manufacturers are acting ‘prematurely’ when asking excipient suppliers to provide metal impurity levels, according to a new position paper published by the IPEC Federation, an umbrella organisation which represents the international excipients industry.
The situation has arisen because metal (elemental) impurities are covered in an International Conference on Harmonisation guideline (ICH Q3D) – currently in draft form – and also feature in proposed revisions to the US Pharmacopeial Convention (USP) general chapters on elemental impurity limits and procedures (<232> and <233>).
The revisions are intended to update the methodology used to test for elemental impurities, which have been used for decades, and also establish limits for acceptable levels of impurities such as lead, mercury, arsenic and cadmium in drugs and dietary supplements.
However, “since the draft ICH Q3D guideline is still in early draft form, and not public, the IPEC Federation does not feel it is appropriate for pharmaceutical companies to begin requesting compliance related information to the metal impurity limits listed in this draft at this time,” says the position paper.
“IPEC recommends that excipient suppliers simply respond to these requests by referring customers to the IPEC position paper which explains why it is not possible to provide meaningful information at this time,” said the Federation in a statement.
Many companies are in the process of assessing individual metal impurities in excipients, but final outcomes and presentation of the data will depend on the final version of the ICH Q3D guideline, according to the Federation.
It also points out that because it is the overall dosage form that must meet Permitted Daily Exposure (PDE) limits, the excipient itself is not required to comply with the limits in the ICH Q3D guideline.
The only limits that the excipient must comply with, from a regulatory perspective, are those laid out in pharmacopeial monographs or other specific regulatory references which may apply directly to the excipient.
A workshop on elemental impurities is currently ongoing in Maryland, US, to allow excipient suppliers to share data confidentially and feed it into the ICH Q3D process to develop standards which are “reflective of the unique diversity of excipients”, it added.
Phil Taylor
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