Category: Resource Topic

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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EMA/CAT/80183/2014: Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy Medicinal Products (GTMP)
The EMA guideline on quality, non-clinical and clinical aspects of gene therapy medicinal products (GTMP´s) builds on earlier documentation and [...]
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Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center…
Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one [...]
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FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in…
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot [...]
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Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida…
Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal [...]
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Supplier Assessment Questionnaire Kit
Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual [...]
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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On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims [...]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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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 [...]
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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 [...]
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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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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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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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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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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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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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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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Amidst Fraud Concerns in China, E&C Leaders Ask FDA for Contingency Plan for U.S. Heparin…
FOR IMMEDIATE RELEASE February 2, 2018 Contact: Press Office (202) 226-4972 Amidst Fraud Concerns in China, E&C Leaders Ask FDA [...]
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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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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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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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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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Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry…
FDA is providing final guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities.  [...]
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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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Regulation (EU) 2017/746 of the European Parliament & Council of 4/5/17 on in vitro diagnostic…
The European regulations governing in vitro diagnostic devices have recently been updated, and enter into force on 26 May 2022 [...]
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MHRA GMP Inspection Deficiency Data Trend 2016
The MHRA has improved the way of gathering the inspection deficiency data for 2016. The new data trending can allow [...]
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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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EMA Implementation Strategy of ICH Q3D Guideline
On 08 March 2017, EMA issued an implementation strategy of the ICH Q3D guideline that addresses specific considerations to enable [...]
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EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents
On 6 December 2016 the European Medicines Agency issued a revision to the “ICH guideline Q3C (R6) on Impurities: Guideline [...]
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Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA [...]
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Agreement on Mutual Recognition Between EU Community and US FDA
The US FDA and the EU announced that they have completed an exchange of letters to amend the Pharmaceutical Annex [...]
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Working Group Adds New Resources to Data Integrity Library
The Data Integrity Working Group has added four additional resources (links below) to the Data Integrity Library. We welcome you [...]
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Supplier-Led Working Group Charter
The Rx-360 Supplier-Led Working Group (SLWG) was formed in 2013 as an initiative through which supplier members can share perspectives [...]
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