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.

News

Rx-360 Welcomes Newest Supplier Member mpro5

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Event

APEC RHSC Meeting

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Rx REPORT

Industry News Headlines

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Rx REPORT

Rx-360's New Data Integrity Library Resource

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Rx REPORT

Want to Bring Down Drug Prices? Go After the Middleman The American Prospect An important set of lawsuits target one...

15 August 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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Rx REPORT

Serialization will be good for business, pharma says

22-May-2017 More than 70 per cent of drugmakers believe serialization requirements in the US will positively transform their business processes,...

31 May 2017
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Rx REPORT

Industry News Headlines

Nano Pharmaceutical Market Research, Key Players, Industry Overview,Supply and Consumption … DailyNewsKs Nano Pharmaceutical Market is expected to witness growth of international market with respect...

16 May 2017
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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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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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Audit Reports

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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Audit Report

Gulcicek Kimya VE Ucanyaglar JA – 775

Audit #: JA - 775
Region: Europe
Material: Basic Chemicals/Raw Materials
Company: Gulcicek Kimya Ve Ucanyaglar
Location: Gebze Kocaeli Turkey
Date: 18-19 October 2016
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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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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

APEC RHSC Meeting

18-19 August 2017
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Event

15th Annual Cold Chain Global Forum

25-29 September 2017
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