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The News in Depth

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is seeking help from drug manufacturers in its effort to update monographs for small molecules and excipients that use outdated technology, have safety/environmental concerns, or are missing key aspects.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....

House Committee Chair Towns Asks J&J’s CEO for Detailed Information on McNeil Recall Actions

House Committee on Oversight and Government Reform Chair Edolphus Towns (D-NY) has sent a letter to Johnson & Johnson (J&J) CEO William Weldon requesting additional specific information on a market action taken regarding one of its Motrin products last year. Information requested on what Towns terms a “phantom recall” includes the names of J&J employees who were involved in making the decision to pursue this action, names of the contractors involved, and all records related to the action....

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....
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