Who We Are

The PRST at DIT is engaged in Regulatory Science education and research for the pharmaceutical and medical device industry to enable those involved in the development, manufacture and supply of drug and related health products to deliver safe and effective products for patients and to meet the expectations of the international regulatory community.

 

We actively engage with industry, regulators and academics in order to focus on addressing the challenges and opportunities of implementing Science and Risk based manufacturing approaches.

 

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

“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 PRST is responding to this quality paradigm shift through the development of solutions, such as;

  • Quality Risk Management(QRM) Toolset
  • Research on impact of Uncertainty and Subjectivity in the assessment of risks to quality
  • Process Analytical Technology (PAT) R&D on imaging technologies for use in blending, granulation, roller compaction/milling, compression and packaging processes
  • Development of a ICH Q8,9,10 Implementation Methodology and OPEX /Six Sigma Toolset
  • Research on Knowledge Management tools for capturing, generating and enhancing scientific knowledge
  • Research on impact of new US & EU regulations on Process Validation (PV) for pharmaceutical manufacturers

This work aims to address the FDA's main message from its strategy document published Aug 2011 on 'Advancing Regulatory Science at FDA'  that;

“The challenges of modern product development and globalization underscore the critical importance of modernizing and advancing regulatory science to match advances in basic and applied science and technology."