Process Analytical Technology (PAT) and Quality by Design

PAT

we offer turn key process analytical Technology solutions to the pharmaceutical and biopharmaceutical :

Examples:

  • Laboratory , At-line , On-line , In-line
  • Raw Material Identification
  • Tablet Content Uniformity
  • Blend Uniformity
  • NIR application for pharmaceutical and biopharmaceutical
  • Quality by Design

  • For new product or existing products
  • Develop strategic guidance to implement QbD to maximize product and process to reach best compliance and manufacturing control
  • Provide comprehensive training of QbD , concepts, Risk assessments, DoE, QbD Methodologies, Regulatory requirement FDA, EMA and Health Canada
  • evaluate product quality attributes : API , manufacturing , packaging...etc and establish the desired product state
  • Implement Risk based assessment for product profiles, Establish QTPP, CQA,, CMA,CPP relationships and Design Space.
  • perform Gap analysis adjust product quality to best fit desired quality
  •  

    This document is maintained by webmaster@progamma.ca.
    Copyright ©1998-2020 proGamma Science Corporation