ProPharma Group has combined its extensive background in process validation and control systems to offer a complete PAT solution to clients.Dating back to 1998, ProPharma Group has helped clients bring their pharmaceutical manufacturing processes online to provide valuable information as production occurs, spanning everything from raw materials to batch release.

ProPharma Group has developed a four phased approach to addressing the PAT Initiative, based on the key principles defined by the FDA:

Investigate, Develop, Implement and Monitor. We see these four phases as cyclical as true compliance with the PAT Initiative is attained.

Investigate: We begin with an investigation into your current processes and systems in place to control, monitor and ensure quality of these processes. We then recommend an action plan.

Develop: By working together with you, we select and develop the solutions identified in the action plan. Solutions could include process instrumentation, analytical software, quality procedures and multivariate analysis.

Implement: We’ll help you install, validate and go live with each solution. We team with your resources to perform such tasks as commissioning, qualification and training.

Monitor: We advise you on how to best monitor your implemented PAT solutions to ensure you are getting the results you need. We also help you decide when to return to the investigation phase and continue on the four phase cycle.

ProPharma Group has assembled a team of consultants, partners and specialized experts to work together with you to understand and implement Process Analytical Technology solutions.