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Archive for ‘November, 2010’

Mold Contamination in Claris IV Bags Results in Class I Recalls, Warning Letter and Import Alert

The findings of fungal contamination in IV bags contract-manufactured at Claris Lifesciences’ Ahmedabad, India facility has resulted in a three-product Class I recall, an FDA warning letter and a U.S. import alert on Claris products....
November 30, 2010 | Posted in Asia, GMP Deviations/Warning Letters, GMP Enforcement Activity, Injectable, The News in Depth | Read More »

Contamination Control in Aseptic Processing Draws FDA Warning in U.K.

FDA inspection observations in late July of evidence of mold contamination in a Class 100 aseptic suite and inadequate controls in place to prevent it led to a warning letter to Wrexham, U.K.-based CP Pharmaceuticals at the end of October....
November 30, 2010 | Posted in Europe, GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth | Read More »

China’s Quality Regulatory Process Evolving Toward the Western Model

China’s quality regulatory process is evolving toward the Western model as it draws on and incorporates guidance from the EMA, WHO, FDA and ICH....
November 29, 2010 | Posted in Asia, CMC Review Policy, Marketing Application/General, Master File/Contractor/Supplier, The News in Depth | Read More »

IPQ’s Monthly Update for October 2010 now available

Dominating IPQ’s coverage during October were GMP compliance problems at both U.S. and foreign manufacturing facilities and the insight they provide on where FDA’s concerns lie and how it will respond when product quality is jeopardized....
November 23, 2010 | Posted in The News in Depth | Read More »

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....
November 22, 2010 | Posted in Contracting, Europe, GMP Policy, The News in Depth | Read More »

IPQ Monthly Update — October 2010

Now available, IPQ’s “Monthly Update — October 2010” on key CMC/GMP developments in the US, Europe, and internationally....
November 16, 2010 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

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)....
November 15, 2010 | Posted in Inspection Initiatives, Preapproval, The News in Depth, US/Canada | Read More »

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....
November 14, 2010 | Posted in Authorities, GMP Policy, The News in Depth, US/Canada | Read More »

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....
November 6, 2010 | Posted in Biosimilar, CMC Review Policy, Generic/Biosimilar, The News in Depth, US/Canada | Read More »

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....
November 4, 2010 | Posted in Agency Management, Asia, GMP Deviations/Warning Letters, GMP Enforcement Activity, Inspection Initiatives, The News in Depth | Read More »
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