News

Is the review of the Audit Trail required in Clinical trials?

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

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Audit Trail Review required before Each Batch Release?

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?

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Current Questions and Answers on Data Integrity and Audit Trail Review

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.

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FDA Data Integrity and Compliance with CGMP Guidance for Industry finalised

Data integrity is still topic number 1 for national and international authorities. In 2016, the US-FDA presented a draft guidance on that in form of a questions and answers document. Now, it was finalised on 12 December 2018. Read more about the Guidance for Industry "Data Integrity and Compliance with CGMP".

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PIC/S gives ECA the Opportunity to comment on PI 041-1 (Draft 3) - Data Integrity

The Pharmaceutical Inspection Co-operation Scheme as international association of pharmaceutical inspectors is currently elaborating a document on data integrity. This document was published for comment on 30 November 2018. Among others, the ECA Foundation has been given the opportunity by the PICS to comment on this third draft by 28 February 2019. Read more about the new draft 3 of PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

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How FDA will prioritise Inspections

The US FDA has published a so called internal Manual of Policies and Procedures (MAPP) describing how the agency will prioritise its pharmaceutical inspections.

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Data integrity still in the focus of FDA: new warning letter to Japanese API manufacturer

The topics data and data integrity are still in the focus in FDA inspections. Find out more about the details of a warning letter to Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd.

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Warning letter due to inadequate document management and GMP non-compliant analytical software

Facilities supervised by the FDA should pay great attention to GMP-compliant processes, especially in the areas of manufacture and quality control; otherwise, they risk failing the inspection and receiving a warning letter. Find out what defects regarding document management and analytical software FDA inspectors found at the site of an active substances manufacturer.

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GCP: FDA Draft on Data Integrity in Clinical Studies

The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of  Electronic Data Files and Statistical Analysis Programs.

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MHRA´s Data Protection Policy

The MHRA published its data protection policy on May 25, 2018, the same day the new General Data Protection Regulation came into force in Europe.

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