• What does PAT stand for?  

Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).

  • What is QbD?  

Quality by Design (QbD) has been defined by the United States Food and Drug Administration (FDA) as:

  • Scientific, risk-based, holistic and proactive approach to pharmaceutical development.
  • Deliberate design effort from product conception through commercialization.„
  • Full understanding of how product attributes and process relate to product performance.

 

 

PAT 4 QbD:

 

Hyperflux Raman HTVS Optical Spectrometers (on-line Raman solutions)

microPHAZIR Rx (NIR) for Lyophilisation (Freeze Drying - Lyophilization) application

What does PAT stand for?  In the Pharma arena it stands for Process Analytical Technology, most major Pharma's will have a PAT or Process Engineer team.  Some assess all analytical instrumentation, others just Process equipment.  

 

What is QbD?  In the Pharma arena QbD stands for Quality by Design. QbD is a strategic, logistic and systematic approach to development that enables both product and process understanding and process control, based on solid science and quality risk management.

PAT for Quality by Design (QBD)