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

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U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics

On December 22, 2017, FDA issued a draft guidance to assist applicants and manufacturers of certain licensed biological products in...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
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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
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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U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles

On December 15, 2017, FDA issued a new, draft guidance that describes how FDA intends to implement provisions enacted by...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

U.S. FDA Announces Pilot Program – Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot

On December 28, 2018, FDA announced its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ...

4 January 2018
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BLOG

FY2017 GMP Drug Warning Letter Analysis

This article presents a detailed summary of the drug GMP warning letters issued in FY2017 as well as a comparison...

2 January 2018
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Rx REPORT

U.S. FDA Issues Revised MAPP on Naming of Drug Products Containing Salt Drug Substances

The Manual of Policies and Procedures (MAPP) (effective December 7, 2017) describes how the Center for Drug Evaluation and Research...

27 December 2017
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Rx ALERT

Rx-360 Supplier Led Working Group Publishes White Paper: Quality Elements for Suppliers of Products or Services to GMP Regulated in Spanish

To get your copy in Spanish click here.

4 December 2017
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Rx ALERT

Press Release from First Ever Fight the Fakes Face to Face Partner Meeting

PRESS RELEASE Global coalition in the fight against falsified medicines meets in Brussels as it welcomes its 35th partner Monday...

30 November 2017
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Rx REPORT

FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers

On October 3, 2017, FDA issued draft guidance to assist applicants preparing to submit to FDA abbreviated new drug applications...

28 November 2017
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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...

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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...

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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...

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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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Audit Reports

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
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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
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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
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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
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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
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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
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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 JA - 806
Location: 4-115, Mastuo Hachimantai - Iwate 028-7305 Hachimantai
Date: 13-14 March 2017
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Audit Report

Ajinomoto Saga-Gun JA – 825

Audit #: JA - 825
Region: Japan
Material: API/ExcipientsBasic Chemicals/Raw Materials
Company: Ajinomoto
Location: 450 Morodomi-Tsu, Morodomi- Cho Saga- Gun Saga- Ken 840-2193
Date: 22-23 June 2016
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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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Latest News

News

Rx-360 Africa GDP Work Group Hosts GDP Workshop in Ghana

4 December 2017
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News

Rx-360 Welcomes Newest Supplier Member C&F Technologies

25 October 2017
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Upcoming Events

Event

ASQ – WORLD CONFERENCE ON QUALITY AND IMPROVEMENT

30 April - J May 2018
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Event

American Biomanufacturing Summit 2018

14-15 June 2018
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