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The News in Depth

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....

QbD is Changing the Quality Regulatory Landscape in the US and EU

The quality regulatory initiatives underway as the new decade begins show the strong imprint of ICH Q8-10 at both the agency and international levels. The May 2010 issue of International Pharmaceutical Quality (IPQ) provides an in-depth analysis of how quality by design and the new Q8-10 paradigm is transforming the quality regulatory landscape....

WHO Updating Sterile Processing Guide to Align with US, EU, and Japan

The World Health Organization (WHO) is updating its Annex 4 “Good Manufacturing Practices for Sterile Pharmaceutical Products,” replacing its 1999 version of that document to align with more recent guidance issued by the three ICH countries....

USP Seeks Help from Industry for its Monograph Modernization Effort

The US Pharmacopeia (USP) is seeking help from drug manufacturers in its effort to update monographs for small molecules and excipients that use outdated technology, have safety/environmental concerns, or are missing key aspects. The focus for “modernization” of excipient monographs will be to replace relatively non-specific identification procedures with more specific tests such as infrared spectroscopy....

Novo Nordisk QbD Initiative Gaining Traction Faster Than Anticipated

Novo Nordisk’s broad-reaching quality-by-design (QbD) initiative for protein development is gaining traction faster than the company had anticipated, fueled by buy-in from top management and the production department....

EU and Cambodia Take Steps to Fight Counterfeit Drugs

The EU and Cambodia have recently taken additional steps in the fight against counterfeit drugs: the Council of Europe (EC) updated the EU draft guidance on “falsified medicines,” and Cambodia initiated a crackdown on illegal pharmacies operating in their country.....

Congressional Investigation into J&J Recall Actions Widens to Include Contractors

Contract firms identified as helping Johnson & Johnson with what House Oversight committee chair Edolphus Towns (D-NY) has referred to as a “phantom recall” have now received letters from the committee from asking them to detail their roles in the action....
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