PAT Community of Practice
PMTC Launch PAT Community of Practice
Background: September 2004, the FDA issued their final guidance for the industry, “PAT – A Frame-work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance”. With PAT guidance in place, manufacturing companies now have the FDA’s encouragement to adopt a new, risk-based regulatory framework that has its basis in scientific and engineering principles.
The application of process analytical technology (PAT) in continuous pharmaceutical manufacturing in conjunction with the quality by design (QBD) framework, offers a holistic approach to the production of pharmaceuticals. Despite the advantages and benefits of implementing PAT technologies, numerous questions are still to answer, i.e. what is the best approach to implement PAT? How do we optimally use ML/AI and data analytics? How to enforce automation to support the PAT framework.
Objectives of the PAT-CoP
At PMTC, we aim to setup an Irish community of practice in PAT within the pharmaceutical and MedTech industries, technology providers and academia. This forum will develop a unique opportunity for engagement and networking with industrials and academics/experts involved in the implementation and use of PAT manufacturing and R&D. By creating the PAT-CoP forum, we aim to:
- Provide a platform for knowledge exchange between academia and industry including Pharma, MedTec and Technology providers
- Create a technical/discussion group to support all levels of competences of PAT, Chemometrics and predictive modelling in Ireland.
- Offer an environment for interdisciplinary interactions between different technical groups i.e Process and smart manufacturing, Machine learning (AI) and data analytics
- Provide an opportunity to review the latest development in the field
- Provide an opportunity to review the technical and regulatory guidelines
- Provide an environment for interaction between academia, industry, suppliers industries and regulatory institutions.
- Provide a framework for seminars, workshops and trainings for PMTC members