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

The Plight of BioPharma Supplies at Missionary Hospitals in Africa

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Template / Tool

Supplier Assessment Questionnaire Kit

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Rx REPORT

African Medicines Agency endorsed by Ministers of Health

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Rx REPORT

Rx-360's New Data Integrity Library Resource

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Rx REPORT

The Plight of BioPharma Supplies at Missionary Hospitals in Africa

Faith-based organizations (FBOs) provide a substantial portion of the health care services in many African countries. FBO facilities do consider...

20 September 2017
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Rx ALERT

Rx-360 Supplier Led Working Group Releases Version 2.0 of Supplier Assessment Questionnaire

The Rx-360 Supplier Led Working Group (SLWG) is very pleased to announce the release of version 2.0 of the Rx-360...

19 September 2017
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Rx REPORT

African Medicines Agency endorsed by Ministers of Health

In a collective effort to curb and prevent the circulation of counterfeit drugs in Africa, the Ministers of Health aim...

19 September 2017
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Rx REPORT

FDA Announces Pilot Project Program Under the Supply Chain Security Act

On July 20, 2017, FDA announced its intent to establish a pilot project program under the Drug Supply Chain Security...

3 August 2017
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Rx REPORT

Imperial Logistics Supply Chain Academy – Upcoming Educational Programs

Imperial Logistics Supply Chain Academy’s Receiving Management Program and Inventory Management Program will take place from the 14th – 18th of August 2017...

31 July 2017
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Rx REPORT

Raising Awareness with Fight the Fakes

On July 28th, Fight the Fakes raises awareness around World Hepatitis Day.  According to WHO 2015 World Hepatitis report, 325 million people worldwide...

25 July 2017
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Rx REPORT

CBER Publishes their Updated 2017 Guidance Agenda

CBER recently published their updated Guidance Agenda for 2017.  The following documents have been added to this updated Guidance Agenda:...

12 July 2017
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Rx REPORT

FDA Announces Exemptions from Premarket Notification for Class II Devices

On July 11, 2017, FDA announced a list of class II devices that the Agency has determined based on established...

12 July 2017
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BLOG

2016 Data Integrity Associated Warning Letters

FINAL-VERSION-2016-DATA-INTEGRITY Barbara W. Unger www.ungerconsulting.net

27 June 2017
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Rx REPORT

Industry News Headlines

WHA Bans IP Reference In Substandard And Falsified Medicines Intellectual Property Watch … term “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC medical products) with “substandard...

31 May 2017
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Summary

CANADA GAZETTE – Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need)

The objective of the regulatory amendments is to enable access to drugs that would help address an urgent public health...

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Summary

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.

The Drug Supply Chain Security Act (DSCSA) was signed into law on November 27, 2013. Section 202 of the DSCSA...

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Summary

EUROPEAN COMMISSION – SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 7

The European Commission provided an update to the Questions and Answers regarding “Safety Features For Medicinal Products For Human”.  This...

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FDA – Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act (DSCSA)

On July 20, 2017, FDA issued a Federal Register notice announcing that three (3) public meetings have been scheduled to...

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Summary

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

The European regulations governing in vitro diagnostic devices have recently been updated, and enter into force on 26 May 2022...

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Summary

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices

The European regulations governing medical devices have recently been updated, and enter into force on 26 May 2020 (some exceptions...

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Summary

MHRA GMP Inspection Deficiency Data Trend 2016

The MHRA has improved the way of gathering the inspection deficiency data for 2016. The new data trending can allow...

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Summary

Supply Chain Security Steering Committee Work Group Charter

The Rx-360 Supply Chain Security(SCS) Steering committee provides a strategic framework to efficiently deliver the foundational value of collaboratively resolving...

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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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Audit Reports

Audit Report

Evonik Technochemie GmbH JA – 814

Audit #: JA - 814
Region: Germany
Material: API/Excipients
Company: Evonik Technochemie GmbH
Location: GutenbergstraBe 2 Dossenheim 69221
Date: 7-8 February 2017
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Audit Report

TraceLink – JA – 859

Audit #: JA - 859
Region: United States
Material: Packaging
Company: TraceLink
Location: 400 Riverpark Drive North Reading MA 01864
Date: 13 July 2017
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Audit Report

GE Healthcare Bioscience Bioprocess JA – 788

Audit #: JA - 788
Region: United States
Material: Basic Chemicals/Raw Materials
Company: GE Healthcare Bioscience Bioprocess
Location: 14 Walkup Drive Westborough MA 01571
Date: 3-4 May 2017
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Audit Report

EAG Laboratories JA – 836

Audit #: JA - 836
Region: United States
Material: API/Excipients
Company: EAG Laboratories
Location: 7220 E ABC Lane Columbia MO 63202
Date: 11 July 2017
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Audit Report

Merck S.L.U JA – 798

Audit #: JA - 798
Region: Spain
Material: API/ExcipientsBasic Chemicals/Raw Materials
Company: Merck S.L.U
Location: 08100 Mollet del Valles (Barcelona)
Date: 6-7 March 2017
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Audit Report

Seki sui Medical Co. Ltd JA – 806

Audit #: JA - 806
Region: Japan
Material: API/Excipients
Company: Seki sui Medical Co. Ltd
Location: 2111-2 Oaza Sato Hachimantai
Date: 13-14 March 2017
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Audit Report

Essentra – JA – 833

Audit #: JA - 833
Region: United States
Material: Packaging
Company: Essentra
Location: 1072 Boulder Rd Greensboro, NC 27109, USA
Date: 19-20 April 2017
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Audit Report

Barnhardt – JA – 835

Audit #: JA - 835
Region: United States
Material: Packaging
Company: Barnhardt
Location: 4969 Energy Way Reno, NV
Date: 11 May 2017
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Audit Report

Novacyl JA – 785

Audit #: JA - 785
Region: France
Material: API/Excipients
Company: Novacyl
Location: Rue Gaston Monmousseau 38150 Rousillon, France
Date: 3-4 May 2017
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Audit Report

Essentra – JA – 833

Audit #: JA - 833
Region: United States
Material: Packaging
Company: Essentra
Location: 1072 Boulder Rd Greensboro, NC 27109, USA
Date: 19-21 April 2017
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Latest News

News

Rx-360 Welcomes Newest Supplier Member Unisys

16 August 2017
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News

Rx-360 Welcomes Newest Supplier Member mpro5

10 August 2017
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Upcoming Events

Event

15th Annual Cold Chain Global Forum

25-29 September 2017
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Event

Data Integrity Recognition & Prevention Workshop

26-28 September 2017
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