Simplifying Global Compliance
Items Tagged with 'Compliance'
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. Read More
Australia’s Department of Health and Ageing (DHA) has posted a draft version of legislation establishing the joint Australia New Zealand Therapeutic Products Authority (ANZTPA). Read More
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. Read More
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. Read More
Wyeth will respond this month to Form 483 observations from an FDA reinspection of the company’s Guayama, Puerto Rico, manufacturing facility, the firm recently announced. Read More
Omnicare has entered into a contract with Cardinal Health’s repackaging unit following the long-term care pharmacy’s closure of its Heartland operation, the companies recently announced. Read More
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. Read More
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). Read More
Manufacturers should approach their responses to Form 483s and FDA warning letters with a global perspective, experts said at a recent FDAnews audioconference. Read More
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