New Ph. Eur Monograph on PAT adopted

Recommendation

27-29 February 2024

GMP meets GCP - Live Online Training
Management, Supply and Quality Assurance of Clinical Trials

At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25). According to the EDQM, "the adopted texts help ensure that the Ph. Eur. remains up to date and in line with the latest regulatory developments and scientific state of the art". They will become effective from 1 January 2020 and will be published in 10th Edition of the Ph. Eur.

As reported about the draft of the new chapter 5.25 published in Pharmeuropa 30.1 "PAT can be defined as a system for designing, analysing and controlling manufacturing processes through timely measurements (i.e. during processing) of critical quality attributes (CQA), and critical performance characteristics of raw materials, in-process materials and processes, in order to ensure the quality of the final product".

Interfacing manufacturing processes with analytical techniques is essential in PAT, as it facilitates process development in accordance with quality by design (QbD) principles, enables real-time release testing (RTRT) according to Annex 17 of the EU GMP Guide and supports continuous manufacturing processes (as already reported about Q13 & Q14).

For more information please read the EDQM Press release.