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The News in Depth

New Draft Broadens EU GMP Guide Chapter 7 from Contracting to All Outsourced Activities

The European Commission has released for comment a revision to Chapter 7 of the EU GMP Guide on outsourced activities that expands the scope of coverage and incorporates quality system and risk management principles from ICH Q9&10....

FDA Preapproval Inspections Enhanced by New Guidance, Reviewer Participation

Increased reviewer engagement with investigators is impacting the preapproval inspection (PAI) process and helping FDA address the growing complexity of products and processes it faces in reviewing new drug applications (NDAs) and their supplements (sNDAs)....

House Committee Surveying FDA’s Puerto Rico District 2000-2010 Oversight Activities

The House Committee on Oversight and Government Reform is requesting that FDA provide a wide variety of documents pertaining to the last decade of compliance oversight by its Puerto Rico field office....

Make Interchangeability Decision After Biosimilar Approval, Amgen Urges FDA

A proposal for a two-tiered system that would require a biological product to be approved first as a biosimilar and then later become applicable for “interchangeable” status with a reference product using post-marketing data drew attention at an FDA public meeting on November 2-3 at the agency’s White Oak campus in Silver Spring, Maryland....

Japan’s Foreign Inspections Reveal Communication Chain Gaps

Foreign inspections by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are revealing gaps in the communication chain between marketing authorization holders in Japan, their overseas suppliers and the Japanese caretakers of the supplier’s master files, PMDA’s Liaison Officer with EMA Yoshikazu Hayashi reported at the annual meeting of the Active Pharmaceutical Ingredient Council (APIC) in Barcelona, Spain in late October....

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....
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