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: An Industry Group Like No Other

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Summary

FDA Public Notification of Emerging Postmarket Medical Device Signals

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Rx REPORT

FDA Issues Final Guidance Postmarket Management of Cyber Security in Medical Devices

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Summary

FDA Issues Final Guidance on Quality Agreements

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Rx REPORT

Strict vetting can help fight counterfeit drugs

The World Health Organization (WHO) estimates that about 10 per cent of global pharmaceutical supply is counterfeit and substandard. The...

23 January 2017
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Rx REPORT

FDA says investigations underway into counterfeit medications

ALBANY, GA (WALB) -Justice Department officials say they are concerned that more Americans are buying medication illegally from foreign pharmacies, and...

23 January 2017
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BLOG

Welcome to our newly launched website and the first ever CEO Blog!

As noted in the recently re-launched Newsletter, I mentioned a number of new initiatives and activities in which our Board...

23 January 2017
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Rx REPORT

MHRA Publishes 2015 GMP Inspection Deficiency Data

On January 11, 2017, MHRA published the 2015 GMP inspection deficiency data trend. The top 10 most cited deficiency groups...

17 January 2017
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Rx REPORT

CDER Issues Guidance Agenda for CY 2017

CDER has published their CY2017 Guidance Agenda, which outlines new and revised draft guidances CDER plans to publish during the...

13 January 2017
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Rx REPORT

Modifications to the List of FDA Recognized Standards

On December 23, 2016, FDA modified the list of standards FDA recognizes for use in pre-market reviews (“FDA Recognized Consensus Standards”)....

6 January 2017
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Rx REPORT

FDA Issues Final Guidance on Medical Device Reporting for Manufacturers

On November 8, 2016, FDA issued final guidance to describe and explain FDA’s current regulation that addresses reporting and record keeping...

6 January 2017
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Rx REPORT

FDA Issues Final Guidance on Medical Device Accessories

On Friday, December 30, 2016, FDA issued final guidance is intended to provide guidance to industry and FDA staff about...

5 January 2017
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Rx REPORT

FDA Issues Final Guidance Postmarket Management of Cyber Security in Medical Devices

On December 28, 2016, FDA issued final guidance to inform industry and FDA staff of the Agency’s recommendations for managing...

5 January 2017
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BLOG

Happy Holidays from Rx-360

Dear Rx-360 Community, Partners, and Friends: As the Holiday Season is upon us, we find ourselves reflecting on the past year and...

15 December 2016
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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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Summary

FDA Public Notification of Emerging Postmarket Medical Device Signals

FDA has issued final guidance describing CDRH’s policy for notifying the public about medical device “emerging signals.”  This guidance describes the...

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Summary

EC Publications on Investigational Medicinal Products

December 9, 2015 The European Commission has recently published four (4) new public consultations on Investigational Medicinal Products (IMPs), which...

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Summary

EU GMP Annex 16: Certification by a Qualified Person and Batch Release

December 9, 2015 On October 12, 2015, EMA published GMP Annex 16, Certification by a Qualified Person and Batch Release.  Annex...

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Summary

MHRA announced it signed a Memorandum of Understanding (MOU) with its counterpart body in India

December 17, 2015 On October 5, 2015, the MHRA announced it signed a Memorandum of Understanding (MOU) with its counterpart...

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Summary

FDA Guidance: eCopy Program for Medical Devices

December 17, 2015   On December 3, 2015, FDA issued an updated version of their guidance eCopy Program for Medical Device...

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Summary

The MHRA Inspectorate’s Blog

December 18, 2015 MHRA Inspectorate Blog Discusses “The Global Supply Chain as a Storage Area” The MHRA Inspectorate Blog posted a discussion...

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Summary

GPS Tracking/Monitoring Security Service Providers Presentation Event

January 6, 2016   Location: Pfizer’s Collegeville, Pennsylvania Facility Date: February 3, 2016 Time: 8:00 am to 5:00 pm Contact: Brad...

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Audit Reports

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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Audit Report

Mallinckrodt Pharmaceuticals JA – 531

Audit #: JA - 531
Region: Greenville
Material: API/Excipients
Company: Mallinckrodt Pharmaceuticals
Location: DaOnne Pustelnik 100 Louis Latzer Drive Greenville, IL 62246
Date: 14 May 2015
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Audit Report

M and H Plastics JA – 722

Audit #: JA - 722
Region: Suffolk
Material: Packaging
Company: M and H Plastics
Location: Beccles, Suffolk NR34 8TS United Kingdom
Date: 13-14 October 2015
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Audit Report

Life Technologies (Thermo Fisher Scientific Bioproduction Division) JA -746

Audit #: JA-746
Region: Bedford
Material: Basic Chemicals/Raw MaterialsChromatography Resins
Company: Life Technologies
Location: 2 Preston Ct. & 35 Wiggins Ave Bedford, MA 01730
Date: 10-11 December 2015
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Audit Report

Laminar Medica Limited JA-754

Audit #: JA - 754
Region: Hertfordshire
Material: Packaging
Company: Laminar Medica Limited
Location: Unit 4, Icknield Way Industrial Estate Icknied Way Tring, Hertfordshire, HP234JX United Kingdom
Date: 1-2 June 2016
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Latest News

News

Rx-360 Launches New Website to Promote Patient Safety

10 November 2016
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News

EMA Probing Wanbury for Falsifying Labels

10 November 2016
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