Rx-360 Supply Chain Security: Prevention of Re-use of Genuine Packaging Components for Counterfeit Products
Counterfeit medicines are a serious and growing problem. Some estimates indicate that the global trade in counterfeit drugs approaches $200 [...]
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FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
Update [11/22/2019] FDA is alerting patients and health care professionals to two repackagers’ voluntary recalls of ranitidine. The medicines are being [...]
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Rx-360 Supply Chain Security: A Comprehensive Supply Chain Security Management System Version 2.0
Protecting patients is the obligation of the pharmaceutical industry and is fundamental to our business. Supply Chain Security (SCS) is [...]
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Rx-360 Natural Disaster Contingency Planning
As we read the news around the world it almost seems that there is some sort of natural disaster occurring. [...]
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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On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims [...]
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Over Half Of U.S. States Have Now Seen Fatalities From Counterfeit Drugs Made With Fentanyl
During a roundtable discussion focused on the nation’s worsening opioid crisis, advocates for ensuring a safe drug supply shared new [...]
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FDA Alerts Drug Makers of a Recall of Porcine Thyroid API from Sichuan Friendly Pharmaceutical…
FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, [...]
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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets
Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of [...]
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Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due…
Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 [...]
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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 [...]
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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 [...]
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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 [...]
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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 [...]
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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 [...]
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RECALL: Blood Pressure Medication, Valsartan, Recalled Due to Possible Contaminants
The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears [...]
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Definitions of Suspect Product & Illegitimate Product for Verification Obligations Under the Drug Supply Chain…
The Drug Supply Chain Security Act ( DSCSA ) amended the Federal Food, Drug, and Cosmetic Act ( FD&C Act [...]
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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 [...]
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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 [...]
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Cargo Theft in the Pharmaceutical Industry – What Does it Really Cost?
Introduction Most modern pharmaceutical supply chains are complex, global, outsourced, and decentralized. In addition, many supply chains are vulnerable to [...]
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Upstream Supply Chain Mapping
Introduction: This white paper reviews the present state of how the pharmaceutical industry maps its upstream raw material supply chain [...]
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Upstream Supply Chain Security Risk Assessment Tool
About: This tool has been developed in excel document: Tab 1:Cause and Effect Matrix Tab 2: Failure Mode and Effects [...]
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Supply Chain Mapping Spreadsheet
About: This tool allows you to map your supply chain. The template has been developed in word document so that [...]
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Upstream Supply Chain Security
Purpose and Scope: This white paper reviews the present state, current challenges, and recommended best practices for several upstream supply [...]
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Counterfeit, Unapproved and Diverted Drugs Threats & Monitoring Process
Introduction and Overview: The distribution and sales of Counterfeit, Unapproved and Diverted Drugs (CUDD) are a global concern for pharmaceutical [...]
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