The International Pharmaceutical Excipients Council (IPEC) and the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, of which IPEC is a member, have been taking a hard look at where the key challenges lie in implementing the elemental impurity standards in the new Step 2b draft of ICH Q3D and what tools they can provide to assist the pharmaceutical regulatory community in addressing them.
The goal of IPEC and the Coalition is to bring the pharmaceutical industry, its suppliers, the pharmacopeias and regulators together to collaborate and reach a common understanding of the implementation problems that need to be solved and where the most effective and efficient, science and risk-based solutions lie.
With ICH having reached agreement on harmonized elemental impurity limits, now emerging into high relief are the not insignificant issues around what further testing will actually need to be done to make the risk assessments that ICH Q3D calls for meaningful, who is going to do it, and how the results are going to be communicated and assessed for compliance through the regulatory chain.
Already emerging from the IPEC/Coalition pipeline are:
● an updated standardized information request form and cover letter that drug manufacturers can provide to their ingredient suppliers to better target and streamline the communication process regarding the ICH elemental impurity issues
● a risk-assessment tool for drug manufacturers to use in calculating permissible daily exposure (PDE) based on their specific formulation and daily dosing as they obtain information on potential ingredient elemental impurity levels, and
● a position paper providing data and information supporting the use of extractable/bio-accessible metal content vs. total dissolution/metal content, what can be learned from other industries on this score, and recommendations on how USP could move forward on the issue.
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