The PSRT is engaged in researching and developing implementation guidance and technology solutions for the pharmaceutical manufacturing industry to enable them to meet the expectations of the international pharmaceutical regulatory community.
For the past 30 years, the increasing demands to protect public health and ensure high quality, safe and effective medicines has driven the development of the regulations and guidance associated with Good Manufacturing Practice (GMP). Between 2005 and 2009 the International Conference of Harmonisation (ICH), which brings together the drug regulatory authorities of Europe(EU), Japan (MHLW) and the United States(FDA) and the pharmaceutical industry , published three important harmonized guidance documents referred to as ICH Q8R2, Q9 and Q10 which outline the international regulatory communities position on;
- ICH Q8R2: Pharmaceutical Development, August 2009
- ICH Q9 : Quality Risk Management, November 2005
- ICH Q10: Pharmaceutical Quality Systems, June 2008
These guidance documents were produced in order to;
“Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science.” ICH briefing Brussels, July 2003
This regulatory initiative has formalized the quality paradigm shift in the industry regarding the necessary application of sound science and quality risk management principles to promote modern manufacturing techniques, process improvement and continual innovation.
The principles of this paradigm shift have been outlined in the ICH concept of Quality by Design (QbD). QbD promotes "A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management." ICH Q8R2 Part II, Glossary of Terms
The work of the PSRT is responding to this quality paradigm shift through the development of solutions, such as;
- Quality Risk management (QRM) Toolset
- Process Analytical Technology (PAT) R&D on imaging technologies for use in
blending, granulation, roller compaction/milling, compression and packaging processes
- QbD/ ICH Q8,9,10 Implementation Framework and Toolset
This work aims to address the ICH Implementation Working Group's main message that;
"Science is no longer isolated; it is living across the lifecycle of the product/process within a
Quality Management System"
ICH Implementation Training, Nov 2010