News

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.

More
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" .

More
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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
x
Search