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

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

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Document

Supplier Assessment Questionnaire Kit

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Rx REPORT

Rx-360's New Data Integrity Library Resource

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News

Safeguarding The Pharma Supply Chain: A Progress Report On The Rx-360 Consortium

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Rx REPORT

EMA: Quality of Medicines Questions and Answers: Part 1

EMA has recently published additional questions and answers related to whether or not variations are required for removal of the...

13 April 2017
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Rx REPORT

Falsified Medicines in Europe: Enhanced Analytical Capacity for National Laboratories Through the OMCL Network

The European network of Official Medicines Control Laboratories has highlighted how new analytical techniques will support national authorities, such as...

13 April 2017
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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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Summary

FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

On December 9, 2016, FDA issued guidance for industry entitled ‘‘Drug Supply Chain Security Act Implementation: Identification of Suspect Product...

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Summary

EMA Implementation Strategy of ICH Q3D Guideline

On 08 March 2017, EMA issued an implementation strategy of the ICH Q3D guideline that addresses specific considerations to enable...

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Summary

EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents

On 6 December 2016 the European Medicines Agency issued a revision to the “ICH guideline Q3C (R6) on Impurities: Guideline...

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Summary

Agreement on Mutual Recognition Between EU Community and US FDA

The US FDA and the EU announced that they have completed an exchange of letters to amend the Pharmaceutical Annex...

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Summary

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA...

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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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Audit Reports

Audit Report

Xcellerex

Region: United States
Material: Basic Chemicals/Raw Materials
Company: Xcellerex
Location: 170 Locke Drive Marlborough MA 01752
Date: 15-16 June 2015
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Audit Report

Merck & Cie JA – 737

Audit #: JA - 737
Region: Switzerland
Material: Audit Guide for Chromatography ResinsBasic Chemicals/Raw Materials
Company: Merck
Location: Weisshausmatte 6460 Altdorf Switzerland
Date: 23-24 February 2016
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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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Latest News

News

The APEC Medical Products Supply Chain Security Toolkit Goes Live

30 March 2017
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News

Rx-360 Welcomes Newest Observer Member IFPW

28 March 2017
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Upcoming Events

Event

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

26-29 June 2017
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