Items Tagged with 'Compliance'


CDER to Require eCTD Format for Electronic Submissions

Drug manufacturers choosing to submit applications to the U.S. Center for Drug Evaluation and Research (CDER) electronically — as opposed to on paper — will have to use a particular electronic format called the electronic common technical document (eCTD) starting Jan. 1, 2008, a U.S. Food and Drug Administration (FDA) official said.

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U.S. FDA to Revise QualitySystems Guidance Per ICH Q10

The U.S. Food and Drug Administration (FDA) will update its current good manufacturing practices (cGMPs) quality systems (QSs) guidance to conform to international pharmaceutical QS guidelines, the agency said March 23 at a Drug Information Association conference.

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MHRA Offers Firms Flexibility in Electronic Submissions -- for Now

In an effort to ease manufacturers into electronic common technical document (eCTD) formatted submissions, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is accepting electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but which lack an extensible markup language (XML) backbone.

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Demonstrating Employee Competence a Key Goal

A key goal of Good Manufacturing Practice (GMP) training is to bring employees up to a satisfactory level of competence that can be proven to FDA inspectors, according to David Markovitz, president and founder of GMP Training Systems.

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FDA Updates Investigations Operations Manual

The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).

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