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Revamped EudraGMP Database May Make GMP Noncompliance Statements Public

Jan 28th, 2013

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In the revamp of its EudraGMP database, the European Medicines Agency (EMA) is considering making GMP noncompliance statements publicly available.

The database currently contains publicly-available information on manufacturing authorizations and GMP certificates, and also houses GMP noncompliance statements, which are now only available to regulators.  The noncompliance statements are issued to a manufacturer after a GMP inspection when the firm is deemed to be out-of-compliance by agency inspectors with the EU GMPs.

At a December PDA/EMA conference in Cascais, Portugal, EMA Manufacturing and Quality Compliance Section Head David Cockburn reported that “in the last week or so, there has been agreement in principle that the GMP noncompliance statements will become public.”

He emphasized that it is an agreement “only in principle,” and that the earliest it could happen would be in late February, along with the launch of three other new modules.  “But a lot of work has to be done between now and then to enable this to happen,” Cockburn commented.

Other new modules due to be launched next month will contain: ● EU GMP inspection planning information ● wholesale distribution authorizations, and ● GDP certificates.  The wholesale distribution authorization and GDP certificates modules will be in the public domain.

February 26th is the target date for launch of the new modules.  “That is when the database becomes available for member states to upload data,” the EMA official noted.  “I can’t tell you how long it will take to fully populate the database.”

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See related IPQ stories:

EMA GMP Chapter Draft Revisions Focus on Current Compliance Focal Points from Shared Facilities to Defect Investigations

International Joint API Inspection Pilot Program Sees Positive Results

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