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IPEC Federation announces the publication of the updated Qualification of Excipients for Use in Pharmaceuticals Guide and Checklist (Version 3, 2026). The guide, originally published in 2008, has been refreshed to ensure alignment with regulatory expectations. This guide is widely used globally.
Qualification of excipient suppliers is fundamental to secure the excipient supply chain and has never been more important in relation to recent tragic events related to adulterated substances used in making medicines.
Kaushik Desai, secretary general, International Pharmaceutical Excipient Council of India, said that the guide developed by the IPEC Federation with support from its regional chapters in the Americas, Europe, Japan, China, and India. This updated qualification guide aligns with global regulatory standards. It represents a significant step toward harmonizing excipient qualification across the pharmaceutical industry. This alignment is particularly critical for the Indian market following past incidents involving substandard excipients. As members of IPEC India, leading suppliers adhere to these frameworks to ensure the highest quality and safety standards. This guide is designed to be used alongside the broader suite of IPEC Federation guidance documents.
The IPEC Qualification of Excipients for Use in Pharmaceuticals guide outlines best practices for establishing and maintaining effective relationships between excipient suppliers and users, with practical recommendations to address key challenges commonly encountered by both parties. By promoting improved collaboration and communication, the guide supports the efficient use of excipients and helps streamline interactions with regulatory authorities. The checklist aims to be a quick reference for topics to consider during the qualification of an excipient for use in medicinal products.
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