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The News in Depth

ICH Q8-10 IWG Making Adjustments Based on Estonia Workshop and Follow-up ICH Meeting

The ICH Q8-10 Implementation Working Group (IWG) has concluded, based on its industry/regulator workshop in Tallinn, Estonia in early June and the IWG’s internal meeting the following week, that refinement of the training model used in the workshop, additional Q&As, and further evaluation of the other ICH quality guidelines for inclusion of Q8-10 principles are needed....

Genzyme Allston Plant Resumes Normal Operations Although Shortages Continue

In a June 29 update, Genzyme clarified its current production status and the impact remediation efforts are having on its ability to release product and supply the market....

New FDA Draft Guidance Reduces Reporting Burden for CMC Postapproval Changes

A new draft guidance from FDA specifies 40 types of low-risk manufacturing changes that will now quality for annual report filing and represents a significant step in the agency’s effort to reduce the number of supplements that have to funnel through the Center for Drug Evaluation and Research (CDER) clearance process....

USP Upgrading Bioassay Coverage; FDA Weighs In on Bioassays at AAPS’ National Biotech Meeting

The US Pharmacopeia (USP) is upgrading its coverage related to bioassays to keep pace with the evolving science and technology. In its July/August Pharmacopeial Forum, USP is proposing revisions for public comment to General Chapters <1032>, <1033>, and <1034>, which address the design, validation, and analysis of bioassays respectively....

Consulting Firms Are Busy in Wake of Stronger FDA Enforcement, Lachman’s Sturgeon Reports

Heightened scrutiny of drug manufacturers by FDA has led to an increase in warning letters, injunctions, and import alerts, and in turn has significantly increased the demand for consulting services, Lachman Consultants’ President Roy Sturgeon told the participants in an investor “conference call” sponsored by New York-based Lazard Capital Markets on June 22....

FDA Tabling Public Biosimilar Discussions While Digesting Complexities of New Legislation

FDA speakers at recent conferences have been open about their inability to discuss biosimilar issues at this time, while they digest the implications of the recently-passed Patient Protection and Affordable Care Act (PPACA)....

Pfizer Finds QbD a “Large Value Proposition,” VP Migliaccio Tells DIA Annual Meeting

Pfizer’s assessment of its data on the impact of implementing quality by design indicates that QbD is “a very large value proposition,” Global Manufacturing Network Performance Senior VP Gerald Migliaccio reported at DIA’s Annual Meeting in Washington, D.C. on June 16....

FDA Wants to See More Transparency Between Drug Companies and Contractors on Sponsor’s Application and Contractor’s GMP Status

FDA investigators will be looking for more transparency between a sponsor and its contract sites regarding the sponsor’s drug application commitments and the contractor's plant-wide GMP status, FDA Cincinnati District Investigator and Preapproval Manager Kathleen Culver emphasized at a Global Outsourcing Conference at Xavier University on June 14....

FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape

FDA is fast-tracking a set of changes to 21 CFR Part 211 targeting control of raw materials, excipients and components used in pharmaceutical manufacturing. Also being completed are changes impacting management responsibilities, self-inspections, defect investigations, change control, training documentation, and use of purified water in manufacturing....

EU Moving to Tighten GMP Requirements on Outsourcing and Supply Chain Control

Changes to the EU regulations that govern technical agreements, outsourced activities, active pharmaceutical ingredient (API) supply chains, and the storage and transit of medicines are in progress and expected to be released soon for public consultation....
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