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.

Rx REPORT

Rx-360's New Data Integrity Library Resource

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Document

Supplier Assessment Questionnaire Kit

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News

Rx-360 Welcomes Newest Supplier Member ISN

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Event

CoE for Global Medical Product Quality & Supply Chain Security Pilot Program

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Rx REPORT

Working Group Adds New Resources to Data Integrity Library

The Data Integrity Working Group has added four additional resources (links below) to the Data Integrity Library. We welcome you...

22 March 2017
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Rx ALERT

Second Chinese company found shipping APIs from a banned manufacturer

If the FDA has serious concerns about the APIs or drugs made at a facility outside the U.S., it often will...

17 March 2017
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Rx REPORT

Rx-360’s New Data Integrity Library Resource

About the Data Integrity Library: This library is a collection of up to date publications associated with the topic of data...

13 March 2017
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Rx REPORT

Monitoring and Reporting Working Group Posts New Resources

The Monitoring and Reporting Group has just launched three more resources to the resource library. We invite you to share these...

10 March 2017
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Rx REPORT

Industry News Headlines

Counterfeit drugs are putting the whole world at risk Popular Science A blister pack of faked Artesunate, a drug used to treat malaria,...

9 March 2017
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Rx REPORT

Industry News Headlines

EU and US Pledge to Recognize Each Other’s GMP Inspections By Randi Hernandez In a landmark decision, the United States FDA...

2 March 2017
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Rx ALERT

Longshore Union Calls for East Coast Port Shutdown

By Marex  2017-02-23 14:01:00 The International Longshoremen’s Association (ILA) is calling for a shutdown at ports along the eastern seaboard and Gulf...

24 February 2017
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Rx ALERT

Pharmaceutical Annual Cargo Theft Report

Report provided by the Transported Asset Protection Association TAPA Americas collects, records, analyzes and reports on cargo theft data for...

20 February 2017
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Rx ALERT

Falsified packs of cancer drug Votrient found in Germany

Securing Industry 18FEB2017 – Axicorp GmbH has discovered another falsified medicine in the legitimate supply chain in Germany, this time...

18 February 2017
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Rx REPORT

Industry News Headlines

Drug-peddling brothers from Lithuania ran international counterfeit medicinescam from Oxford … Oxford Mail Enforcement officers raided the house and storage...

15 February 2017
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Document

Data Integrity Library

About the Data Integrity Library: This library is a collection of up to date publications associated with the topic of data...

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Document

FDA Office of Generic Drugs Issues 2016 Annual Report

On February 28, 2017, FDA’s Office of Generic Drugs (OGD) posted its 2016 annual report.  The report discusses Generic Drug...

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Document

CDER Issues Updated CY2017 Guidance Agenda

CDER has issued their updated CY2017 Guidance Agenda (issued February 15, 2017), which outlines new and revised draft guidances CDER...

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Summary

FDA Medical Device Inspection Observation Summary Published

FDA has recently published their Medical Device Inspectional Observation Summary for FY2016.  This information can assist industry in improving device...

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Summary

Annual Reporting by Prescription Drug Wholesale Distributors: Questions and Answers

On January 10, 2017, FDA issued draft guidance addressing questions and clarifying FDA’s expectations for annual reporting to FDA by...

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Summary

US GAO Report on FDA’s Drug Inspection Program

In 2008 and 2010, GAO examined FDA’s foreign drug inspection program and recommended it conduct more foreign inspections.  In another...

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Summary

Supplier-Led Working Group Charter

The Rx-360 Supplier-Led Working Group (SLWG) was formed in 2013 as an initiative through which supplier members can share perspectives...

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Summary

Data Integrity Working Group Charter

The Data Integrity Working Group of Rx-360 focuses on an area that has been the subject of US FDA enforcement...

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Webinar

Webinar: Cargo Theft in Pharmaceutical Industry: What does it really cost?

Webinar Purpose To present the outcomes of the white paper. Busy professionals do not have time to research the true...

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Summary

FDA Issues Final Guidance on Quality Agreements

FDA has issued final guidance for industry entitled ‘‘Contract Manufacturing Arrangements for Drugs: Quality Agreements.’’ This guidance describes FDA’s current...

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Audit Reports

Audit Report

Parker Hannifin Corp JA – 561

Audit #: JA - 561
Region: California
Material: Basic Chemicals/Raw Materials
Company: Parker Hannifin Corp
Location: 2340 Eastman Ave Oxnard, California 93030, USA
Date: 8-9 April 2015
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Audit Report

Nuova Ompi JA – 770

Audit #: JA - 770
Region: Padvoa
Material: Packaging
Company: Nuova OMPI
Location: Via Molinella, 17-35017 Piombiono DesePavoda-Italy
Date: 30 March - 30 May 2016
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Audit Report

Asahi Kasei Medical Co., Ltd. (Bioprocess Division) -Oita

Audit #: JA - 801
Region: Oita-shi
Material: Basic Chemicals/Raw Materials
Company: Asahi Kasei Medical Co., Ltd
Location: Planova Oita Plant 2111-2 Oaza Sato, Oita-shi, Oita 870-0396, Japan
Date: 17 November 2016
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Audit Report

Asahi Kasei Medical Co., Ltd. (Bioprocess Division) -Nobeoka

Audit #: JA - 800
Region: Nobeoka-shi Miyazaki
Material: Basic Chemicals/Raw Materials
Company: Asahi Kasei Medical Co., Ltd
Location: Planova Plant 6-4158 Asahi-machi, Nobeoka-shi Miyazaki 882-0847, Japan
Date: 15-16 November 2016
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Audit Report

Nuova OMPI JA – 579

Audit #: JA - 579
Region: Padova
Material: Packaging
Company: Nuova OMPI
Location: Via Molinella, 17 35017 Piombino Dese, Padova, Italy
Date: 30-31 March 2015
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Audit Report

Nipro Glass JA – 606

Audit #: JA - 606
Region: Virginia
Material: Packaging
Company: Nipro Glass
Location: 194 Duckworth Drive, Chase City, Virginia 23924
Date: 19-20 May 2015
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Audit Report

NAMSA, Sterilization Products Division JA – 525

Audit #: JA - 525
Region: Ohio
Material: Basic Chemicals/Raw Materials
Company: NAMSA, Sterilization Products Division
Location: 6750 Wales Road Northwood, Ohio 43619
Date: 26 May 2015
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Audit Report

Morton Salt JA – 551

Audit #: JA - 551
Region: Ohio
Material: API/Excipients
Company: Morton Salt
Location: 151 South Industrial Avenue Rittman, Ohio 44270
Date: 11 August 2015
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Audit Report

Mingtai Chemical Co. Ltd JA – 707

Audit #: JA - 707
Region: Taoyuan Hsien
Material: API/Excipients
Company: Mingtai Chemical Co. Ltd
Location: 1142, Shin Hsing Rd., Bah-Der City, Taoyuan Hsien, Taiwan, ROC
Date: 19-20 November 2015
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Audit Report

Medistri SA JA – 579

Audit #: JA - 579
Region: Domdidier
Material: Packaging
Company: Medistri SA
Location: 96 Route de l’industrie, 1564 Domdidier Switzerland
Date: 9 April 2015
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Latest News

News

Rx-360 Welcomes Newest Supplier Member ISN

20 March 2017
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News

Global Vigilance How Rx-360 Began

2 March 2017
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Upcoming Events

Event

USP-APEC RHSC Securing Medical Product Quality Through the Supply Chain

28-31 March 2017
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Event

PDA Metro Chapter Day Auditing Symposium

28-28 March 2017
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