Event

2018 Rx-360 Conference

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News

Takeda Sponsors at Silver Level

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Template / Tool

Supplier Assessment Questionnaire Kit

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Document

Data Integrity Library

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Rx ALERT

Chinese Vaccine Maker Made 500,000 Substandard Baby Vaccines: Xinhua

A Chinese drug company produced nearly 500,000 substandard vaccines for babies, roughly double an earlier estimate by authorities investigating a...

15 August 2018
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Rx ALERT

EU Sees One in 5,000 Cancer Risk from Tainted China Heart Drug

The European Medicines Agency estimates there could be one extra case of cancer for every 5,000 patients taking a common...

15 August 2018
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Rx ALERT

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg...

14 August 2018
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Rx ALERT

EMA Reviewing Medicines Containing Valsartan from Zhejiang Huahai Following Detection of an Impurity

The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company...

9 August 2018
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Rx ALERT

Proposed Changes To WHOIS System Privacy Will Help Hide Internet Criminals, NABP Director Warns

Every week brings new details of the negative externalities of social media and e-commerce websites. But fake bots aren’t the...

9 August 2018
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BLOG

Rx-360 CEO Monthly Blog

Are we on the verge of the next “Heparin contamination scare”?   I woke up this morning and like I...

8 August 2018
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Rx ALERT

FDA Updates on Valsartan Recalls

Update [8/2/2018] FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included...

3 August 2018
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Rx ALERT

China Heart Drug Sold Globally May Have Had Impurity Since 2012

The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago...

3 August 2018
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Rx ALERT

MHRA Says Falsified Medicines Directive Could Cost £500m Over Ten Years

The Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that implementing the Falsified Medicines Directive (FMD) in the UK...

27 July 2018
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Rx ALERT

Could Blockchain Solve China’s Food and Drug Safety Problems?

A scandal involving a Chinese pharmaceutical firm that forged documents relating to a rabies vaccine for babies has sparked a...

27 July 2018
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Summary

Announcement on the Matters related to filing and Joint Review & Approval of Active Pharmaceutical Ingredients, Pharmaceutical Excipients, and Pharmaceutical Packaging Materials for Drug Products

The CNDA (formerly CFDA) has issued an announcement which clarifies the expectations for when excipient suppliers, API suppliers and packing...

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Summary

PIC/S GMP GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I

PIC/S has developed guides aimed at promoting the harmonization of GMP standards and guidance documents.  The PIC/S GMP Guides have...

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White Paper

Taking a Collaborative Approach to Secure Donated Medicines

Providing and receiving donated medicines to populations in need through NGO partners can serve as a tremendous benefit to patients...

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Webinar

Webinar: Supplier Assessment Questionnaire Version 2.0

Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own...

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Summary

Implementation of International Council for Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use Guidance Q3C(R6): Impurities: Guideline for Residual Solvents

The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the...

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Webinar

Webinar: Quality Elements for Suppliers of Products or Services to GMP Regulated Companies

This webinar focuses on the white paper that was released by the Supplier Led Working Group. Quality Elements for Suppliers...

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Webinar

Webinar: GMP Audit Manual – Data Governance and Data Integrity

This webinar focuses on the Data Integrity Audit Manual released by the Data Integrity Work Group. This data integrity audit...

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Webinar

Webinar: Quality Agreements Guide Version 2.0

This webinar focuses on Version 2.0 of Best Practices from Quality Agreements published by the Rx-360 Supplier Led Working Group....

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Summary

Annex 1 to the Good Manufacturing Practices Guide – Manufacture of Sterile Drugs (GUI-0119) – Summary – Canada.ca

Health Canada’s Annex 1 to the Good Manufacturing Practices Guide for Manufacture of Sterile Drugs (GUI-0119) will be implemented 01...

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Summary

MHRA ‘GXP’ Data Integrity Guidance and Definitions

The MHRA published ‘GXP’ Data Integrity Guidance and Definitions in March 2018. The scope of this guidance is designated as ‘GXP’...

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Audit Reports

Audit Report

Purac Biochem BV

Audit #: JA - 813
Region: Europe
Material: API/Excipients
Company: Purac Biochem BV
Location: Arkelsedikj 46, 4206 AC Gorinchem Netherlands
Date: 24-26 April 2018
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Audit Report

Xellia Pharmaceuticals Ltd JA – 894

Audit #: JA - 894
Region: Germany
Material: API/Excipients
Company: Xellia Pharmaceuticals Ltd
Location: Szallas utca 3 Budapest Hungary
Date: 28-29 November 2017
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Audit Report

BASF A/S JA – 730

Audit #: JA - 730
Region: Germany
Material: API/Excipients
Company: BASF A/S
Location: Malmparken 5 DK - 2750 Ballerup, Denmark
Date: 20-21 June 2017
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Audit Report

DSM Nutritional Products AG – JA – 786

Audit #: JA - 786
Region: Switzerland
Material: API/Excipients
Company: DSM Nutritional Products
Location: Werk Siseln, Hauptstrasse 4 Sisseln Switzerland
Date: 26-27 June 2017
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Audit Report

Avantor Performance Materials JA – 854

Audit #: JA - 854
Region: United States
Material: API/Excipients
Company: Avantor Performance
Location: 600 North Broad Street Phillipsburg NJ 08865
Date: 6-7 September 2017
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Audit Report

Sartorius Stedim Biotech JA – 755

Audit #: JA - 755
Region: Europe
Material: Packaging
Company: Sartorius Stedim Biotech
Location: Km 24 Route de Zaghouan 1145 Bourbiaa BP 87 Mhamdia Tunisia
Date: 17-20 May 2016
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Audit Report

Rondo-Pak – JA – 848

Audit #: JA - 848
Region: United States
Material: Packaging
Company: Rondo-Pak
Location: 138 Winston Churchhill Ave, PMB 549 San Juan, PR 00926
Date: 15-16 August 2017
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Audit Report

Ajinomoto JA – 783

Audit #: JA - 783
Region: Brazil
Material: API/Excipients
Company: Ajinomoto
Location: Via Anhanguera Km 131 CEP 13480-970 Limeira Brazil
Date: 19-20 October 2016
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Audit Report

Ajinomoto Co JA – 819

Audit #: JA - 819
Region: United States
Material: API/Excipients
Company: Ajinomoto Co
Location: 4020 Ajinomoto Drive Raleigh, North Carolina 27610
Date: 1-2 November 2017
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Audit Report

Imerys Minerals JA – 890

Audit #: JA - 890
Region: Australia
Material: Basic Chemicals/Raw Materials
Company: Imerys Minerals
Location: 3610 Glenelg Hwy Pittong VIC
Date: 9-10 November 2017
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Latest News

News

Rx-360 Announces Tracy Cooper as Working Group Member of the Month!

8 August 2018
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News

Avantor Sponsors at Bronze Level

8 August 2018
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Upcoming Events

Event

LogiPharma

5-6 September 2018
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Event

2018 Rx-360 Conference

25-26 September 2018
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