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

2018 Rx-360 Conference

Learn More
Rx REPORT

Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes

Learn More
Template / Tool

Supplier Assessment Questionnaire Kit

Learn More
Rx REPORT

Rx-360's New Data Integrity Library Resource

Learn More
Rx REPORT

WHO Issues Report on Global Surveillance and Monitoring System for Substandard and Falsified Medical Products

On February 14, 2018, the World Health Organization (WHO) issued a report summarizing data gathered by the WHO Global Surveillance...

16 February 2018
Read More
Rx REPORT

Work Plan for the Biologics Working Party (BWP) for 2018

On December 14, 2017, the EMA published its adopted Work Plan for the Biologics Working Party 2018. The Plan outlines...

13 February 2018
Read More
Rx REPORT

Work plan for the joint CHMP/CVMP Quality Working Party (QMP) for 2018

On December 4, 2017, the CHMP/CVMP Working Party issued their final work plan for the joint Quality Working Party (QWP)...

13 February 2018
Read More
Rx ALERT

Rx-360 Supplier Led Working Group Releases Version 2.0 of Product Information Module (Module 3)

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

13 February 2018
Read More
Rx ALERT

Amidst Fraud Concerns in China, E&C Leaders Ask FDA for Contingency Plan for U.S. Heparin Shortage

FOR IMMEDIATE RELEASE February 2, 2018 Contact: Press Office (202) 226-4972 Amidst Fraud Concerns in China, E&C Leaders Ask FDA...

6 February 2018
Read More
Rx REPORT

CDER Issues Planned Guidance Agenda for CY2018

On January 19, 2018, CDER issued their updated CY2018 Guidance Agenda, which outlines new and revised draft guidances CDER plans...

22 January 2018
Read More
Rx REPORT

U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics

On December 22, 2017, FDA issued a draft guidance to assist applicants and manufacturers of certain licensed biological products in...

5 January 2018
Read More
Rx REPORT

FDA Provides Notice to Public of Website Location of CDRH FY 2018 Proposed Guidance Development

On December 12, 2017, FDA issued a Federal Register Notice announcing the website location where the Agency will post two lists of...

4 January 2018
Read More
Rx REPORT

U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles

On December 15, 2017, FDA issued a new, draft guidance that describes how FDA intends to implement provisions enacted by...

4 January 2018
Read More
Rx REPORT

U.S. Announced Proposed Program – Voluntary Malfunction Summary Reporting Program for Manufacturers

On December 26, 2017, FDA issued a Federal Register Notice announcing a proposed program permitting medical device manufacturers to submit malfunction medical...

4 January 2018
Read More
Summary

FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

On November 27, 2017, FDA issued a draft guidance to help trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) understand their compliance...

Read More
Summary

ICH Q12 on Pharmaceutical Product Lifecycle Management was issued for public consultation

ICH Q12 Draft Guideline provides the framework to facilitate the management of post-approval CMC changes in a predictable and efficient...

Read More
Summary

Annex 1 on Manufacturing of Sterile Medicinal Products, of the Eudralex Volume 4

Annex 1 “Manufacturing Of Sterile Medicinal Products” of the EU GMP Guide was first published in 1971, since then it...

Read More
Summary

EU SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 8

The European Commission Directorate-General for Health and Food Safety has prepared Question and Answers document to address questions regarding 2019...

Read More
Webinar

Webinar: Training of AuditsPLUS Database

Main Discussed Topics What’s happening at Rx-360 Overview of Rx-360 Audit Program Step by step audit system training

Read More
Summary

EMA Guideline on Manufacture of the Finished Dosage Form

The purpose of this guidance is to provide clarification on the type and level of information to be included in...

Read More
White Paper

Integrating a Third Party Audit Provider into an Existing Supplier Quality Management Process

The increase in requirements and expectations from both Regulators and Customers has challenged the Pharmaceutical Industry to maintain sufficient oversite...

Read More
White Paper

Quality Elements for Suppliers of Products or Services to GMP Regulated – Spanish Version

Los Elementos de Calidad para los proveedores de productos o servicios que proveen a empresas reguladas por las Buenas Prácticas...

Read More
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. ...

Read More
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)...

Read More

Audit Reports

Audit Report

AMCOR Flexibles JA – 873

Audit #: JA - 873
Region: United States
Material: Packaging
Company: Amcor Flexibles
Location: 6850 Midland Industrial Drive Shelby KY, United States
Date: 22-23 May 2017
Read More
Audit Report

Jungbunzlauer, JA – 839

Audit #: JA - 839
Region: Canada
Material: API/Excipients
Company: Jungbunzlauer
Location: 1555 Elm Street Port Colborne, Ontario L3K 5V5 Canada
Date: 18-19 May 2017
Read More
Audit Report

SAFC BioScience (Broadway) JA – 849

Audit #: JA - 849
Region: United States
Material: Basic Chemicals/Raw Materials
Company: SAFC BioScience
Location: 3506 S. Broadway St. Louis MO 63118
Date: 17-18 July 2017
Read More
Audit Report

GE Healthcare BioScience Bioprocess

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
Read More
Audit Report

TEVA/ PLANTEX TAPI unit of API Division TEVA Pharmaceutical Industries JA – 756

Audit #: JA - 756
Region: Europe
Material: API/Excipients
Company: TEVA/ PLANTEX TAPI unit of API Division TEVA Pharmaceutical Industries
Location: 1 Hakadar St., Industrial Zone, P.O.Box 160, Netanya 4210101 Israel
Date: 31 August 2016
Read More
Audit Report

MG GULCICEK International Fragrance Company, Turkey JA -775

Audit #: JA - 775
Region: Turkey
Material: Basic Chemicals/Raw Materials
Company: MG GULCICEK International Fragrance Company, Turkey
Location: Gülçiçek Kimya ve Uçanyağlar San. ve Tic. A.Ş. GOSB Güzeller Organize bölgesi Tembelova alanı 3300 sokak, No:3306 Gebze Kocaeli, Turkey
Date: 18-19 October 2016
Read More
Audit Report

Whatman International JA – 797

Audit #: JA - 797
Region: United Kingdom
Material: Basic Chemicals/Raw Materials
Company: Whatman International
Location: The Maynard Centre Cardiff
Date: 1 June 2017
Read More
Audit Report

DSM Nutritional Products Inc JA – 734

Audit #: JA - 734
Region: United Kingdom
Material: Basic Chemicals/Raw Materials
Company: DSM Nutritional Products Inc
Location: Drakemyre, Dalry, Ayrshire, Scotland KA24 5JJ
Date: 25-26 October 2016
Read More
Audit Report

Sigma-Aldrich Ireland Ltd JA – 810

Audit #: JA - 810
Region: Germany
Material: API/Excipients
Company: Sigma-Aldrich Ireland Ltd
Location: Vale Road Arklow Co Wicklow Ireland Y14EK 18
Date: 4-5 April 2017
Read More
Audit Report

Siegfried Pharma Chemikalien Minden GmbH JA – 822

Audit #: JA - 822 and JA - 766
Region: Germany
Material: API/Excipients
Company: Siegfried Pharma Chemikalien Minden GmbH and BASF Pharmachemikalien GmbH
Location: Karlstrasse 15 Minden 32423 Germany
Date: 29-30 August 2017
Read More

Latest News

News

Rx-360 Welcomes Newest Manufacturer Member Novo Nordisk

22 February 2018
Read More
News

Rx-360 Welcomes New CEO/COO

2 February 2018
Read More

Upcoming Events

Event

ASQ – WORLD CONFERENCE ON QUALITY AND IMPROVEMENT

30 April - J May 2018
Read More
Event

American Biomanufacturing Summit 2018

14-15 June 2018
Read More

Twitter Updates

Not yet a member? Join Today