Event

2018 Rx-360 Conference

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News

Congratulations to our Working Group Member of the Month!!!

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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 ALERT

Rx-360 Supplier Led Working Group Releases Best Practices for Quality Agreements Version 2.0.

The Supplier Led Working Group is pleased to announce the release of Best Practices for Quality Agreements Version 2.0. Quality...

17 April 2018
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Rx ALERT

FDA Orders Recall of Salmonella-Tainted Kratom Products Nationwide

Various brands of kratom supplements have been linked to nearly 90 cases of salmonella across 35 states. Click Here to...

4 April 2018
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BLOG

Rx-360 CEO Monthly Blog

Networking and Learning: I have always been a big believer in mindset of learning from others, whether they are peers,...

2 April 2018
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Rx ALERT

Rx-360 Data Integrity Working Group publishes GMP Audit Manual – Data Governance and Data Integrity

The Data Integrity Working Group is pleased to announce the release of the GMP Audit Manual – Data Governance and...

27 March 2018
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Rx REPORT

FDA Office of Pharmaceutical Quality Issues Their Annual Report

On February 28, 2018, FDA’s Office of Pharmaceutical Quality published their first public annual report describing their 2017 accomplishments.  The...

8 March 2018
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BLOG

Rx-360 CEO Monthly Blog

Over 20 years ago this month I began my career in the world of healthcare.  At the time I was...

28 February 2018
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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
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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
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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
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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
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Template / Tool

Guide: Best Practices for Quality Agreements Version 2.0

Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply...

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Summary

GMP Guide for Drug Products GUI-001 Canada

This document offers guidelines for interpretation of Good Manufacturing Practices (GMP) as applied in Canada in order to comply with...

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Template / Tool

GMP Audit Manual – Data Governance and Data Integrity

This data integrity audit manual provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories...

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Summary

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims...

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Summary

EU SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS – VERSION 9

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

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Summary

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

The Drug Supply Chain Security Act ( DSCSA ) amended the Federal Food, Drug, and Cosmetic Act ( FD&C Act...

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Summary

FDA Unique Device Identification: Direct Marking of Devices

Unique Device Identification:  Direct Marking of Devices is a guidance document issued by the FDA on 17 November 2017 to...

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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...

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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...

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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...

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Audit Reports

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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Audit Report

Invitrogen JA – 799

Audit #: JA - 779
Region: Australia
Material: Basic Chemicals/Raw Materials
Company: Invitrogen
Location: New South Wales Australia, and Auckland 1006 New Zealand
Date: 22-24 February 2017
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Audit Report

Xcellerex (GE Healthcare) JA – 787

Audit #: JA - 787
Region: United States
Material: Basic Chemicals/Raw Materials
Company: Xcellerex
Location: 170 Locke Drive Marlborough MA 01752
Date: 4 May 2017
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Audit Report

W.R. Grace (Elkridge Warehouse) JA – 855

Audit #: JA- 855
Region: United States
Material: Basic Chemicals/Raw Materials
Company: W.R. Grace
Location: 6610 Cabot Road Baltimore, MD 21226 United States
Date: 16 June 2017
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Latest News

News

Congratulations to our Working Group Member of the Month!!!

30 March 2018
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News

Sparta Systems Sponsors at Gold Level

19 March 2018
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Upcoming Events

Event

Integrating the Rx-360 Joint Audit Program into an Existing Supplier Quality Management Process

24 April 2018
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Event

IPR Center 10-Year Anniversary Celebration 2008-2018

26 April 2018
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Twitter Updates

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