Rx-360

An International Pharmaceutical Supply Chain Consortium

Rx-360’s mission is to protect patient safety by sharing information and developing processes to improve the integrity of the health care supply chain and the quality of materials within the supply chain.

Event

Rx-360 Annual Conference Partnering for Patients

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News

Rx-360: An Industry Group Like No Other

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Rx REPORT

Concerns of Rising China Drug Sales in the United States

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BLOG

Rx-360 Blog – Welcome to Our New Channel!

Welcome to the Rx-360 new Blog! Our Blog will give us a unique opportunity to share subject matter expert content,...

1 November 2016
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Rx REPORT

Has the Insolvency of Hanjin Shipping Negatively Impacted Your Shipments?

Hanjin Shipping is a large shipping company based out of South Korea. Pursuant to many news reports, Hanjin had many...

22 September 2016
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Rx ALERT

FDA Takes Action Banning Imports From 4 Indian and Chinese Firms Under GDUFA’s User Fee Provisions

The FDA on Wednesday banned imports from Chinese and Indian generic drug companies because they failed to pay fees and...

14 September 2016
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Rx REPORT

Concerns of Rising China Drug Sales in the United States

As recently reported by Bloomberg: China Drug Sales to the U.S. Grow Despite Safety Concerns at Home Yet even as...

1 September 2016
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Rx REPORT

FDA Published the Quality Metrics Technical Conformance Guide

On June 27, 2016, FDA published the Quality Metrics Technical Conformance Guide – Technical Specifications Document Version 1.0 (Guide).  This...

23 August 2016
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Rx REPORT

EMA Publishes Update to “Quality of Medicines Questions and Answers Part 1″

The European Medicines Agency (EMA) published a new question and answer on July 29, 2016 regarding Active Substance – Active Substance...

22 August 2016
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Rx REPORT

FDA Publishes Modifications to the List of Recognized Standards

The FDA has modified the list of standards FDA recognizes for use in pre-market reviews (“FDA Recognized Consensus Standards”).  Specifically, this publication...

19 August 2016
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Rx REPORT

EMA Questions and Answers: Good Manufacturing Practice – Data Integrity

The European Medicines Agency has released new GMP guidance to ensure the integrity of data that are generated in the...

15 August 2016
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Rx REPORT

Summary of the Draft WHO HVAC GMPs for Non-Sterile Products

WHO has issued a revision to their supplementary guidelines on GMP for HVAC systems for non-sterile pharmaceutical dosage forms.  This...

14 June 2016
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Rx REPORT

Rx-360 Applauds Law Enforcement and Regulatory Authorities Involved in a Successful PANGEA IX

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action...

10 June 2016
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2014 Germany Symposium

October 29, 2014 Cologne, Germany Presentations Title Welcome and Rx-360 Overview Reasons for Rx-360’s Success MHRA Global Supply Chain Impacts Overview...

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Document

WHO issues draft guidance: “Testing of Suspect Spurious/Falsely-Labelled/Falsified Counterfeit Medicines”

On October 20, 2016, WHO issued draft guidance titled “Testing of Suspect Spurious/Falsely-Labelled/Falsified Counterfeit Medicines”.  This document provides technical guidance...

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Presentation

Survey Results: Fees Charged by Suppliers for the Opportunity to Conduct cGMP Audits

The survey was closed on May 18, 2009, and the results are summarized below in a PDF file and the raw...

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Presentation

USA Rx-360 Launch Meeting Presentations and Polling Results

June 5, 2009 Washington D.C., USA Presentations Title Rx-360 Overview US Department of Commerce – The Global Impact of Counterfeit...

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Presentation

Europe Rx-360 Launch Meeting Presentations and Polling Results

November 10, 2009 GSK House, UK Presentations Title Rx-360 Overview Legal Considerations and Challenges Waste Facilities Audit Association Presentation Rx-360...

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Summary

PIC/S Publishes Data Integrity Guidance

PIC/S has published, on a draft basis, a guidance on Good Practices for Data Management and Integrity in Regulatory GMP/GDP...

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Document

Supplier Assessment Questionnaire Kit

Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual...

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Presentation

Rx-360 Annual Conference 2016 Presentations: Partnering for Patients

Inspiration. Collaboration. Commitment. Rx-360 Annual Conference. The quality revolution is here. What are you doing about it? We connect and...

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Webinar

Webinar: Upstream Supply Chain Mapping

Webinar Purpose White Paper overview and to communicate survey’s outcomes. Main Discussed Topics Supply Chain Security Steering Committee Overview End...

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Webinar

Webinar: Supplier Assessment Questionnaire

Webinar Purpose To present the Questionnaire’s outputs and showing the efficiencies to both suppliers and pharmaceutical manufacturers. Main Discussed Topics Rx-360...

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Audit Reports

Audit Report

Merck KGaA, Germany, JA-536

Audit #: JA-536
Region: Europe
Material: API/ExcipientsBasic Chemicals/Raw MaterialsPharmaceutical Excipients
Company: Merck KGaA
Location: Darmstadt, Germany
Date: 28-30 April 2015
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Audit Report

Report Title

Audit #: JA-612
Region: United States
Material: Basic Chemicals/Raw Materials
Company: Air Products & Chemicals
Location: Glenmont, NY
Date: 21-22 December 2015
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Audit Report

Chemische Fabrik

Audit #: JA-594
Region: Europe
Material: API/Excipients
Company: Chemische Fabrik
Location: Budenheim, Germany
Date: 14-15 July 2015
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Latest News

News

Rx-360 Launches New Website to Promote Patient Safety

10 November 2016
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News

EMA Probing Wanbury for Falsifying Labels

10 November 2016
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