News

Data Integrity from an Inspector's Point of View

Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. Read more about an inspector's viewpoint on data integrity.

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How to prepare for a Data Integrity Inspection

Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.

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Glass Particles due to Delamination

The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk, especially when it comes to parenterals.

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Brexit: U.K. will become 'Third Country' according to EU Statement

The EU Commission and EMA made a clear statement that after 30 March 2019, the Unit Kingdom will become a 'third country'. Both expect marketing authorisation holders to prepare accordingly.

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European authorities' viewpoint on validation deficiencies

An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.

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How to inform EMA about GMP Problems or Data Integrity Issues

On 17 March 2017 the European Medicines Agency (EMA) released a new policy on the handling of information which has been received from external sources about serious concerns, e.g. related to GMP deviations or Data Integrity issues. Please read more about the EMA policy.

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New Analysis of GMP Inspections by MHRA

The British MHRA has published the 2016 GMP inspection deficiency data trend. The report lists interesting examples for all relevant chapters and annexes of the EU-GMP Guidelines.

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Serious FDA Warning Letter issued to European Manufacturer of Sterile Drugs, Part 3 - Data Integrity

As a consequence of significant GMP violations, the American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Read more about the details concerning data integrity issues listed in the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd. 

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How important is "Data Governance" for your Company?

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.

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Is Senior Management really responsible for GMP?

Yes, it is! As you can see in a recent case from Denmark, where the Danish Medicines Agency requires that the CEO of a repackaging facility needs to be replaced.

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