Overview What's New Certificates of Medicinal Products Counterfeit Medicines Good Clinical Practice Overview Inspectors Working Group Procedures and Guidance Q&A Good Laboratory Practice Good Manufacturing Practice / GDP Overview Inspectors Working Group EudraGMP database Compilation of Procedures Joint Audit Programme Q&A PhV Overview Inspectors Working Group Procedures and Guidance Inspection Coordination GCP GLP GMP PhV PMF VAMF International Cooperation MRAs AU CA CH JP NZ US FDA ICH-VICH Process Analytical Technology Overview Q&A Product Defects and Recalls Quality Working Party Overview Guidelines Q&A Sampling and Testing Fees Inspection Links

Inspections - Process Analytical Technology

Overview

The term "Process Analytical Technologies (PAT)" has been used to describe "a system for designing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes for raw and in-process materials and also processes with the goal of ensuring final product quality". The PAT initiative focuses on building quality into the product and manufacturing processes, as well as continuous process improvement.

Quality by design is an established concept in Europe. Even before the introduction of the Common Technical Document (CTD), the regulatory systems required information on the pharmaceutical development of the medicinal product. This part of the dossier focused on a comprehensive analysis of the active substance, the choice of the composition, the manufacturing method, as well as the identification of the critical process parameters and the development of suitable analytical methods.

While the requirements for gaining a level of process understanding are not new, it is recognised that the use of multivariate analysis, in combination with modern process analytical chemistry methods and knowledge management tools can enhance the identification of critical parameters that affect the process and thus result in a more in-depth process understanding. One of the goals is to ensure that all sources of variability affecting a process are identified, explained and managed by appropriate process measurements, so that the finished product consistently meets its predefined characteristics from the start ("right first time"). This is in accordance with the fundamental principle that quality cannot be tested, but is instead built into the medicinal product by design.

In order to support the PAT activities in EU, an EMEA PAT team was created in November 2003. It is a forum for dialogue and understanding between the Quality Working Party and the Ad Hoc Group of GMP/GDP Inspectors Woeking Group with the aim to review the implications of PAT and to ensure that the European regulatory framework and the authorities are prepared for and adequately equipped to conduct thorough and effective evaluations of PAT-based submissions. The team's mandate provides further information on the make-up and aims of the team.

The EMEA PAT team believes that the current regulatory framework in Europe is open to the implementation of PAT in marketing authorisation applications. Reference is made to the existing guidance on Development of Pharmaceutics (CPMP/QWP/054/98), the Note for Guidance on Parametric Release (CPMP/QWP/3015/99) and Annex 17 to the EU GMP Guide. In addition, the ICH Guideline on Pharmaceutical Development (ICH Q8), now adopted by EU, also includes provisions on the use of PAT applications. In order to clarify the EMEA PAT team's position on a number of issues raised by the Industry, a "Questions and Answers" document and a reflection paper have been published. The PAT team will regularly update these documents to reflect new developments and to include accumulated experience.

Documents of interest:

 

Send all queries regarding this content to: gmp@ema.europa.eu