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

Pharma Supply Blockchain Forum

Learn More
Document

Supplier Assessment Questionnaire Kit

Learn More
Rx REPORT

Rx-360's New Data Integrity Library Resource

Learn More
News

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

Learn More
BLOG

2016 Data Integrity Associated Warning Letters

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

27 June 2017
Read More
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
Read More
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
Read More
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
Read More
Rx REPORT

New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017

FDA has updated the list of guidance documents intended for publication by CDER in 2017.  The only change from the...

10 May 2017
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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...

Read More
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...

Read More
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...

Read More
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...

Read More
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...

Read More
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...

Read More
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...

Read More
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...

Read More
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...

Read More
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...

Read More

Audit Reports

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
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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
Read More

Latest News

News

Rx-360 China Work Group Hosts Data Integrity Work Shop

16 June 2017
Read More
News

The Medicine Maker Power List 2017

2 May 2017
Read More

Upcoming Events

Event

Big Changes in DC – What Pharma, Biotech and Supplier Quality, Regulatory, and Supply Chain Security Execs Need to Know Now!

18-18 July 2017
Read More
Event

ICH GCP Training

17-19 October 2017
Read More

Twitter Updates

Not yet a member? Join Today