A new how-to guide was published by the International Pharmaceutical Excipients Council (IPEC) to assist the pharmaceutical industry in complying with new labeling and reporting requirements related to microplastics that have been intentionally inserted into pharmaceuticals.
According to IPEC, the document provides guidance to excipient manufacturers and users on how to prepare for compliance and summarizes key elements of the restriction proposal.
The European Chemicals Agency (ECHA) defines microplastics as "small, usually microscopic solid plastic particles" and includes polymers, which are used in formulations to facilitate drug delivery (and the regulation applies to solid polymers with a particle size less than 5 mm).
This document reflects IPEC Europe and IPEC-Americas’ current understanding of the ECHA’s “Proposal for an EU-wide Restriction on Intentionally Added Microplastics” and may be subject to change until the proposal is formally adopted and more is learned about the practical consequences of its implementation.
Click this LINK for detailed information on reporting microplastic use in pharmaceuticals.
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