New GMP Journal Article on Analytical Instrument Qualification and System Validation

On the GMP Journal website you can find both all single articles issued in the GMP Journals so far as well as the complete issues - freely available to everybody interested.

In the online version, you can easily browse through every issue and read the articles on your PC or tablet. You can also download or directly share the complete issue.

New Issue

In the new issue, you will find articles on the following topics:

• Development of modern Pharmaceuticals, Vaccines and more
• CTR Implementation - A QP's Perspective
• Real-World Data (RWD) and Real-World Evidence (RWE) to Support Medicinal Product Development
• Product, Process, People
• Handling external Personnel in the GMP Environment
• Valsartan
• GMP Hot Spots as seen in the Warning Letters
• ICH Q7 Training Week
• Analytical Instrument Qualification and System Validation

The ECA Analytical Quality Control Group's New Guide

The latter article covers the ECA Analytical Quality Control Group's new document, titled  "Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation".

This guide provides scientifically supported qualification strategies that consider the intended use of the instrument or system. The lifecycle approach presented deliberately deviates from the traditional 4Q model. Instead, it offers a more flexible framework aimed at delivering a unified lifecycle model suitable for analytical instruments and computerized laboratory systems, with a particular focus on GMP-compliant instruments. The approach aligns with the proposals currently under discussion as part of the revision of the USP General Chapter.

The guide can be downloaded as PDF file in the members' area of the AQCG website.

PharmaLab 2024

The PharmaLab Congress, the event for all pharmaceutical laboratory sectors, will be held for the 12th time this year. This year’s program features a new track on Analytical Instrument Qualification and System Validation (AIQSV). Board members of the ECA AQCG will be part of the speaker team, with the track moderated by Dr. Christopher Burgess, Chairman of the AQCG Board.

We invite you to join us from 25-27 November 2024 in Düsseldorf/Neuss. Tickets include access to the social event on 26 November, which offers an opportunity to connect with the speakers and colleagues from other companies in a relaxed atmosphere.

For more information about the program, please visit the PharmaLab 2024 website.