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IPQ Inside the global regulatory dialogue

The News in Depth

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Australia’s TGA Publishes Updated Draft Guidance on Clearance of Products Manufactured Overseas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

The Combination of GMP & Unapproved Drug Problems Continues to Prompt FDA Warning Letters

Warning letters to a pair of over-the-counter (OTC) drug manufacturers just released by FDA indicate that the marketing of unapproved drugs continues to escalate the agency’s response when GMP problems are found....

Product Quality Responsibilities Shared Between CMOs and Sponsor Firms Under FDA Scrutiny

FDA is putting industry on notice that relationships between sponsors and contract manufacturing organizations (CMOs) will be receiving close attention during upcoming agency inspections....

FDA Investigator Training Reflects Changing Technology, Regulatory Approaches and New Hire Profile

FDA’s Office of Regulatory Affairs (ORA) is adapting its training to reflect changing technologies and regulatory approaches, and a bolus of new investigators with divergent experience....

J&J’s “Phantom Recall” and Communication with FDA Probed During House Hearing

Johnson & Johnson’s “phantom recall” of subpotent Motrin and its communications with FDA were focal points at a US House of Representatives Committee on Oversight and Government Reform hearing on September 30....

Temperature and Storage Conditions Top the List of Major/Critical Deficiencies in MHRA GDP Inspections

Temperature and storage conditions were the most common Good Distribution Practice (GDP) deficiencies ranked “major” and “critical” by the UK Medicines and Healthcare products Regulatory Agency (MHRA) during inspections conducted from January to June of 2010....
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