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GDP: Are Inspectors looking for Data Integrity?

Data Integrity is still a hot topic in GMP inspections. And in the GDP area data integrity is also increasingly becoming a subject, as some examples from the MHRA show.

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FDA opens Docket on Software Products

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

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Missing Audit Trail Review led to Warning Letter

Chinese manufacturer Zhejiang Ludao Technology received an FDA Warning Letter in February, 2018. During the FDA inspection, the missing Audit Trail Review for the HPLC system was particularly criticised.

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ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide

With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.

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New MHRA "GxP Data Integrity Guidance and Definitions" published

On 09 March, 2018, the British supervisory agency MHRA published the final version of its guideline on data integrity which has been available as a draft since July 2016. Find out more on a first analysis of the new document "GXP Data Integrity Guidance and Definitions" .

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How is the Data Governance System to be implemented in your Company?

The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented? Find out more about the requirements and specifications of the PIC/S guideline for the pharmaceutical Data Governance System.

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Regulatory requirements for Audit Trail Reviews

Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain. Read more about the EU, PIC/S and FDA requirements concerning Audit Trails and their reviews.

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Track & Trace: New Questions and Answers published by the EU

The next version 8.0 of the catalogue containing questions and answers on practical implementation and technical aspects of serialisation requirements as per delegated act EU 2016/161 has become available on 22 November. Find more information about version 8.0 of the Q&A on EU FMD DR regarding serialisation.

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USA: Track & Trace Realisation Postponed by a Year

In June, the FDA reported that the enforcement of requirements for the safety of supply chains will be postponed by a year. The new date is now November 27, 2018. Find out more about the change of the date in the FD&C Act.

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EudraVigilance: EMA's new Signal Management Guide

In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.

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