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The News in Depth

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....

IPQ’s September “Monthly Update” on Key CMC/GMP Developments in the US, Europe, and Internationally is Now Available

How regulators will be evaluating and enforcing quality risk management (QRM) received particular attention across the global regulatory landscape this past month. UK’s medicines agency and WHO both released guidance addressing QRM inspection expectations – the former in the form of an FAQ, the latter as a draft guideline for comment. The September IPQ Monthly Update also includes a discussion by FDA’s drug compliance office of the pivotal role of supplier/manufacturer communication in managing supply chain risks....

WHO Guideline on QRM Taking Shape

The World Health Organization (WHO) asked specific stakeholders in August to comment on a working draft of a detailed guideline it is preparing on the expectations for quality risk management (QRM) in pharmaceutical manufacturing. The guideline will update WHO’s advice to industry and regulatory bodies in the risk assessment area and align it with more recent documents published by other international regulatory authorities....

FDA Could be a PIC/S Member by Year’s End

The evaluation committee for the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is expected to recommend FDA’s acceptance into the 37-member organization at the next PIC/S meeting in Kuala Lumpur, Malaysia in November. Membership accession could follow by year’s end.
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