APIC: FAQs on Data Integrity

Recommendation

19-21 June 2023
Munich, Germany

ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis
Part of the ICH Q7 Training Courses 2023

In April 2023, the Task Force "Data Integrity" of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document provides numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.

After the introduction, the document is divided into the following subsections:

• Digital and electronic signatures 
• Password management 
• Access management 
• Record life cycle management 
• Various

Depending on the number of questions received, the individual paragraphs contain different amounts of explanations. As the document is intended to provide assistance in the area of data integrity, you can always contact the Task Force with new or missing points at the e-mail address given in the document.

"Data Integrity Frequently Asked Questions (FAQ)" can be found on the APIC website in the "Publications" tab. Many other guidance documents on the subject of active substances can also be found here.