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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....

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....

MHRA Inspectors Will Look For “Risk Registers,” SOPs and Periodic Review in Quality Risk Management Systems

British inspectors when inspecting drug manufacturers will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments, according to a “frequently asked questions” (FAQ) document recently-published by the UK's Medicines and Healthcare products Regulatory Agency (MHRA)....

CDER Will Focus on Part 11 Compliance in Upcoming Inspections

FDA’s Center for Drug Evaluation and Research (CDER) will be conducting a series of inspections of drug manufacturers that will evaluate the industry’s understanding of and compliance with the Part 11 regulations. The inspection findings will be used to assess whether or not its related regulations and guidance need to be adjusted....

International Joint API Inspection Pilot Program Sees Positive Results

The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken....

Facility Listing Errors and Missing Development Data Draw Withhold Recommendations From FDA’s NJ District

Facility listing errors on the application and a lack of availability of development data source documents during pre-approval inspections are causing the New Jersey District to recommend withholding drug approvals, its investigations branch director Myriam Sosa told DIA’s June Annual Meeting....

CBER Releases Updated Compliance Program Guide on Inspection of Biological Drug Products

The Center for Biologics Evaluation and Research (CBER) released in June a revised version of its Compliance Program Guidance (CPG) 7345.848, “Inspection of Biological Drug Products,” which combines and replaces previous versions of CPGs covering related biological products and provides inspectional guidance to investigators for conducting biennial or for-cause inspections across the biologics spectrum....

FDA Proposing More Transparency on Inspection Findings, Recalls, and Drug Filings

An FDA task force released on May 19 a set of transparency principles for public comment which propose to change what GMP and CMC documents and information are available to the public and with what timing. The proposals include making more information available more rapidly regarding GMP inspections, enforcement activities, and investigational, marketing and supplemental filings....

Protecting the Public Health Trumps Explicit Legislative Mandate, FDA’s Chief Counsel Tells FDLI

FDA’s mandate to protect the public health requires making decisions in situations where there is no law explicitly empowering it to act, FDA Chief Counsel Ralph Tyler stressed at the Food and Drug Law Institute (FDLI) Annual Meeting in late April. In turn, Tyler explained that a key role for FDA lawyers is to be advocates for the agency in helping it reach its policy and enforcement goals in situations where waiting for approval from Congress does not allow a timely enough decision....
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