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....
September 30, 2010 | Posted in
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Now available, IPQ’s “Monthly Update -- September 2010” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications has been expanded to include breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.”
Preview Sample Copy of IPQ “Monthly Update — September 2010″
As a non-subscriber, we are offering you a preview sample of the IPQ Monthly Update — September 2010, comprised of the first three pages of the actual issue. You will notice on the first page in the table of contents the stories you are missing by [...]
September 29, 2010 | Posted in
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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....
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.
J&J’s CEO William Weldon has been invited to appear before the House Committee on Oversight and Government Reform to explain the contents of e-mail messages uncovered in the committee’s investigation into the company’s recall of children’s medicines earlier this year....
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)....
FDA will be holding a two-day public hearing to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation. The meeting is set for November 2-3 at FDA’s White Oak campus in Silver Spring, MD....
Key players in the US House of Representatives have put on the table a draft of comprehensive legislation aimed at strengthening FDA’s recall and overseas inspection authorities and requiring new supply chain accountability for drug companies. The bill is intended to help FDA respond to the increasing challenges it faces in regulating a global pharmaceutical marketplace....
An excipient master file (EMF) system in the EU would facilitate the review process, spur excipient R&D and harmonize with other regulatory systems, advocates are saying....
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