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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.

Congressional Committee Has More Questions for J&J’s Weldon

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....

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)....

FDA Gathering Biosimilar Stakeholders for Input on Implementing the New Legislation

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....

US House Proposing to Equip and Fund FDA for Increased Global Oversight

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....

Excipient Master File System Advocated for EU

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....

Ongoing FDA Concerns with Procedure Compliance, Media Fill Practices and Environmental Excursions at BMS’ Manati, PR Plant Draw Warning Letter

Findings by FDA during a mid-March inspection at Bristol-Myers Squibb’s (BMS) injectable operations in Manati, Puerto Rico of problems with procedure and media fill compliance – previously noted in 2005 and 2009 inspections – contributed to a late-August warning letter to the firm....

KV Resumes Drug Shipments of Its First Product After Successful FDA Inspection

KV Pharmaceuticals announced on September 10 that it will restart shipment of its potassium chloride capsule product Micro-K after a successful inspection in August of its St. Louis facility and a letter from FDA this month giving the firm permission to resume manufacturing and distribution of the product....
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