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The News in Depth

FDA Extends False Claims Act to GMP Violations in $750 Million GSK Settlement

The Department of Justice (DoJ) announced in late October that SB Pharmco Puerto Rico (PR) – a subsidiary of GlaxoSmithKline (GSK) – has agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs produced between 2001 and 2005 at its now-closed Cidra, PR facility....

Increasing Cargo Theft of Pharmaceuticals May Have Brand Impact and Result in Recalls

The significant increase in pharmaceutical cargo thefts in the US carries hidden consequences for drug firms beyond the dollar loss they incur, including damaged reputations and the need to perform product recalls....

New Warning Letters in US Focus on Process Validation and Sponsor/Contractor Relations

Drug GMP warning letters issued in mid-October to Hauppage, New York-based Contract Pharmacal and to Advanced Testing Laboratory in Cincinnati, Ohio shed light on FDA’s compliance expectations for two front-burner issues – process validation and sponsor/contractor communications....

FDA, USP and CHPA Team Up to Address OTC Drug Impurity Problems

A committee comprised of experts representing FDA, the US Pharmacopeia (USP) and the Consumer Healthcare Products Association (CHPA) is considering how to strengthen the control of impurities in over-the-counter (OTC) products....

Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe....

FDA Wants More Transparency on Drug Recall Data and Causes

FDA is looking to create more transparency around the data it collects on product recalls and their underlying causes....

FDA-Wide Effort Underway to Clarify and Harmonize CAPA Definitions in Line with New GHTF Guide

FDA Center for Devices and Radiological Health (CDRH) GMP expert Kimberly Trautman is spearheading an effort to clean up and harmonize the definitions around corrective and preventive action (CAPA) across the agency in line with a Global Harmonization Task Force (GHTF) guideline on CAPA that is nearing release....

Australia’s TGA Publishes Updated Draft Guidance on Clearance of Products Manufactured Overseas

TGA has released for comment a draft guideline that clarifies its requirements for GMP compliance by overseas manufacturers and further harmonizes those requirements with other international regulatory bodies....

FDA Raises Tablet Contractor Validation, Aseptic Processing Concerns at Gilead

Tablet contractor process revalidation and aseptic processing of injectible AmBisome were areas of concern addressed in a warning letter from FDA’s Los Angeles District office to San Dimas, CA-based Gilead Sciences in late September....

China’s SFDA Moving Toward Expanding Supply Chain Auditing and Filing Requirements

China’s State Food and Drug Administration (SFDA) has released a draft of a new regulation that would significantly expand the supply chain auditing and filing requirements for manufacturers of active pharmaceutical ingredients (APIs) and packaging as well as drug products....
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