Rx-360 Announces Latest Publication from The Latin America Working Group

PHILADELPHIA, Nov. 25, 2024 /PRNewswire/ -- Rx-360^® is pleased to announce the release of  a Guide to Investigations: A Collaborative Publication by the Rx-360 Latin America Working Group. As an international non-profit, with a mission based on pharmaceutical supply chain integrity, material quality, and patient safety, the Rx-360^® member driven Latin America Working Group is honored to bring this resource to the industry.

The purpose of this guide is to provide tools that enable suppliers and service providers of the Healthcare and Pharmaceutical Industry to carry out robust investigations of nonconformities that help determine the impact on the quality of the product involved and consequently, the potential adverse impact for the patient that uses that regulated product. This guide will support continuous improvement processes and reduce the cost of nonconformity, avoiding recurrence. A robust investigation will determine the root cause of nonconformity. The establishment of proper corrections and corrective actions, which address the root cause, shall prevent a recurrence of the nonconformity.

Jim Fries, CEO of Rx-360 commented, "This publication is the culmination of a lot of hard work by Rx-360 members. This in-depth paper will be a tremendous resource to the pharmaceutical industry and their continuing efforts around patient safety."

The publication addresses that nonconformities can occur during processes but when they occur, it is necessary to report, analyze, and take corrective actions for continuous improvement and to avoid recurrence. A company's quality system must have a procedure for management nonconformities and corrective actions. The investigation of the nonconformity must be thorough and adequate to determine the impact on the product and therefore on the patient. This document provides guidance to help manage nonconformities.

To download a copy of this publication, please visit https://rx-360.org/guide-to-investigations/

About Rx-360:
Rx-360, a non-profit international pharmaceutical supply chain consortium, was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The organization's mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain. To learn more about Rx-360, please visit http://www.Rx-360.org or email jfries@rx-360.org

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SOURCE Rx-360