PAT Implementation Services
Implementing PAT is a challenge if you have to balance it with day-to-day activities.
We employ specialized technical skills to allow you to reap all the benefits.
Talk to our experts
Implementing PAT is a challenge if you have to balance it with day-to-day activities.
We employ specialized technical skills to allow you to reap all the benefits.
PAT Implementation Services
Implementing PAT is a challenge if you have to balance it with day-to-day activities.
We employ specialized technical skills to allow you to reap all the benefits.
Generate Real-Time Measurements of Product Attributes
Minimize Human intervention in measurements
Enable Real-time Release
Seamless implementation in parallel with your day-to-day operations
PAT has been around for almost two decades now, since the launch of the FDA's Process Analytical Technology Guidance for Industry in 2004.
Its relevancy to pharmaceutical manufacturing has been throughly demonstrated through numerous scientific and technical publications on industry cases.
PAT is a fundamental piece of the process control strategy, by providing real-time measurements of relevant material and quality attributes and allowing process adjustments on a timely manner to consistently achieve predefined quality targets.
PAT works hand-in-hand with the Quality by Design (QbD) paradigm and plays a prominent role in the transition to Continuous Manufacturing and as an enabler of real time release.
Additionally, by reducing human intervention in the measurements and decision-making workflow, PAT provides enhanced data integrity.
Regulatory Agencies have consistently supported PAT through the publication of relevant guidelines and by working with industry on the PAT framework.
We employ specialized technical skills that support organisations balancing the implementation of improvements with the day-to-day business activities.
How can 4TE support your PAT efforts
Wether you already have PAT systems in place, or you want to introduce PAT for the first time, our team of MS&T experts, Data Scientists and Quality Risk Management specialists can support on your PAT implementation, by:
Nothing shows our experience better than our work on this topic. Here you can find the resources we have produced on PAT Implementation Services so far.
