PAT in Advanced Pharmaceutical Manufacturing

The first part of the course will review the definition of Process Analytical Technology (PAT) and its benefits for the pharmaceutical industry. These benefits are now clearer with the progress of the PAT initiative.

We have recently proposed a functional definition of Advanced Pharmaceutical Manufacturing (APM) as: “A system that is designed using predictive models, where automation minimizes human intervention while enabling closed loop process control and real time quality assurance, where performance has been optimized to maximize desired process goals, where flexible amounts of product with equivalent attributes can be manufactured, and where equivalent processes can be implemented at multiple locations to manufacture products with equivalent critical quality attributes.” This definition will be discussed and examples will be provided.

Online Course October 30th 10:00am - 11:30am EDT

Rodolfo J. Romañach, Ph.D.

Center for Structured Organic Particulate Systems (C-SOPS) at the University of Puerto Rico

Dr. Romañach is Professor of Chemistry at the University of Puerto Rico – Mayagüez Campus. The motto of his research group is: “We have moved to manufacturing”. He wants to move the analytical laboratory into pharmaceutical manufacturing for real-time monitoring of critical quality parameters, making it possible to control and improve processes. The non-destructive near infrared spectroscopic methods developed by his research laboratory are used in two pharmaceutical processes, and graduates from his group are now working alongside production personnel. A total 10 students have completed their Ph.D. in his lab at UPR-Mayagüez. He wants to develop strong industry university partnerships, and worked in the pharmaceutical industry for over 12 years before joining the Chemistry Department in 1999.

Learning Objectives:

  • Explain the motivations for Process Analytical Technology
  • Explain the functional definition for Advanced Pharmaceutical Manufacturing
  • The role of PAT in Advanced Pharmaceutical Manufacturing

Who will benefit:

This course is directed to the pharmaceutical personnel who will be joining the growing PAT and advanced pharmaceutical manufacturing community. This community includes:

  • Scientists, graduate students, researchers who will be developing the PAT method.
  • Project leaders who develop the business case for a PAT project, and perform risk analysis for the project.
  • Managers and leaders who need to approve the business case.
  • Research and development personnel ready to work with PAT and emerging technologies (focused on bringing new products faster to market).
  • Personnel working on instrument, operational, and performance qualifications of PAT instruments.
  • Automation engineers and personnel who will be working on the integration of the information obtained into the companies information technology structure.
  • Quality assurance and Quality Control personnel who will need to include PAT within the companies’ quality system.
  • Entrepreneur preparing to provide PAT services.

Course schedule:

  • Introduction – 15 minutes
  • Benefits of PAT – 25 minutes.
  • Advanced Pharmaceutical Manufacturing -30 mins
  • Questions and discussion – 20 min.

Questions and Answers session