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Rx-360 Best Practices Quality Agreement Guide

Posted by Josh On October - 5 - 2021

A new Rx-360 best practice guide has just been published. Rx-360 is a non-profit organization that aims to help the pharmaceutical and biotechnology industry improve the security of the pharmaceutical supply chain. It is managed by members of the industry, including manufacturers and suppliers. Your supplier-Led working group has developed a best practice guide for quality agreements and published it on the Rx 360 website. The intent of this guide is “to help customers and suppliers effectively manage the initiation, negotiation, implementation and ongoing maintenance of quality agreements.” The aim is to enable a more efficient and effective negotiation process for quality agreements. The guide aims to identify best practices, e.g. language, external references and resources, as well as reasonable solutions to routine problems that arise during the quality agreement process. By offering perspectives to both suppliers and manufacturers, the guide presents a balanced vision that should help both parties reach a comprehensive and concise agreement. Flexibility and compromise are necessary to understand the requirements of both sides and cooperate. This best practice quality agreement guide is intended to help customers and suppliers effectively manage the initiation, negotiation, implementation and ongoing maintenance of quality agreements. Typically, these agreements exist between drug manufacturers and their suppliers of equipment and services (i.e., manufacturers of APIs, auxiliaries, packaging materials, etc., as well as providers of GxP, analytical or other services to drug manufacturers). The EU MSG Guide, Chapter 7, on outsourced activities, clearly sets out expectations for quality contracts.

Few details have yet been provided in the United States. In 2013, the U.S. Food and Drug Administration (FDA) released draft industry guidelines “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The CFR rules do not expressly require contractors to record their respective responsibilities in order manufacturing agreements, but the rules do require that the responsibilities and procedures of the quality unit be in writing (21 CFR 211.22(d)). Raw Material Supplier Questionnaire Introduction: This questionnaire was developed by the EHPM Quality Working Group. It combines the work done by EHPM in different national federations in development The document follows a particular process ranging from scope and structure to the content of the agreement, verification and maintenance. This allows the user to quickly get to the necessary section if necessary. The process is accompanied by good practices and advice. In addition, the annexes provide a series of comprehensive tools such as: 5 SECTION 2. General site operating information 2.11 Is the site registered with a public control authority (FDA registration, GMP certification, etc.)? If so, please indicate by whom the site is inspected (by regulation or by third parties) and list the inspections carried out in the last three years: 2.13 How often is the site checked on an annual average by customers or third parties? 2.14 Please indicate the regulatory sanctions that have affected the website in the last five years (e.g.B . . .

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