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 ALERT

Request for Information - Disaster Impact Assessment in Puerto Rico and Other Locations

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Rx REPORT

Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes

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Template / Tool

Supplier Assessment Questionnaire Kit

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Rx REPORT

Rx-360's New Data Integrity Library Resource

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BLOG

The fate of the much-hyped mandatory generic prescription plan

It appears that the Ministry of Health has put a kibosh on the much-discussed mandatory generic prescription plan after all. Newspaper...

19 October 2017
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Rx ALERT

Rx-360 Supplier Led Working Group Publishes Whitepaper

The Supplier Led working group is pleased to announce the release of the final version of the Rx-360 Quality Elements...

5 October 2017
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Rx REPORT

Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes

Abbvie Eli Lilly and Company Sensitech Inc TEVA Pharmaceutical Industries Ltd. MSD McKesson Canada GSK Purdue Pharma Technologies Inc Roche...

3 October 2017
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Rx ALERT

Request for Information – Disaster Impact Assessment in Puerto Rico and Other Locations

As you most of the recipients of this information are aware, Puerto Rico and many other locations in the Caribbean...

29 September 2017
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Rx ALERT

Hurricane Maria´s Impacts on Infrastructure and Life Sciences and Healthcare Supply Chains in Puerto Rico

Following the passing of Hurricane Maria on September 20, Puerto Rican news sources have been reporting on widespread damage to...

22 September 2017
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Rx ALERT

Hurricane Maria Threatens to Disrupt Pharma Supply Chain Activity in Puerto Rico and Other Caribbean Islands

This alert has been provided by BSI. September 20, 2017 The recent movement of Hurricane Maria over Puerto Rico and...

20 September 2017
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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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Summary

Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff

FDA is providing final guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities. ...

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Summary

EMA Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use

New legislative requirements from the European Medicines Agency and the European Commission, specifically the new Commission Delegated Regulation (EU) 2016/161)...

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White Paper

Rx-360 Quality Elements for Suppliers of Products or Services to GMP Regulated Companies

Quality Elements for Suppliers of Products or Services to GMP Regulated Companies outlines the basic GMP elements expected of suppliers...

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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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Audit Reports

Audit Report

Recipharm Pharmaservices Pvt. Ltd JA – 867

Audit #: JA - 867
Region: India
Material: Basic Chemicals/Raw Materials
Company: Recipharm Pharmaservices Pvt. Ltd
Location: 34th KM, Tumkur Road T-Begur Nelamangala Bangalore 562123 India
Date: 26 May 2017
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Audit Report

Sangrose Laboratories JA – 850

Audit #: JA - 850
Region: India
Material: Basic Chemicals/Raw Materials
Company: Sangrose Laboratories
Location: Industrial Estate Kallimel PO Mavelikara 690509 Alapuzha District Kerala India
Date: 18-19 May 2017
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Audit Report

Corning Science JA – 809

Audit #: JA - 809
Region: Mexico
Material: Basic Chemicals/Raw Materials
Company: Corning Science
Location: Avenida Industrial del Norte S/N Reynosa
Date: 6 June 2017
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Audit Report

BASF Duesseldorf JA – 738

Audit #: JA - 738
Region: Germany
Material: API/Excipients
Company: BASF
Location: Henkelstrasse 67 Duesseldorf D-40589 Germany
Date: 7-8 December 2016
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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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Latest News

News

Rx-360 Welcomes Newest Supplier Member C&F Technologies

25 October 2017
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News

American Pharma Outsourcing Summit 2017 – Boston, MA

3 October 2017
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Upcoming Events

Event

PMDA-ATC Multi-Regional Clinical Trial (MRCT) Seminar 2018

15-18 January 2018
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Event

ASQ – WORLD CONFERENCE ON QUALITY AND IMPROVEMENT

30 April - J May 2018
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