Dear Scientist,
We all are hearing or using PAT( Process Analytical Technology) from formulation development to production.
Let's first look into origin of PAT tools.
PAT tools can be categorised according to the following:
1. Multivariate tools for design, data acquisition and analysis
2. Process analysers
3. Process control tools includes...
4. Continuous improvement and knowledge management tools
Above is the basic concept of PAT tools on which guideline by FDA release in year 2004.
https://www.fda.gov/downloads/
Regards
Medipharma Official
We all are hearing or using PAT( Process Analytical Technology) from formulation development to production.
Let's first look into origin of PAT tools.
PAT tools can be categorised according to the following:
1. Multivariate tools for design, data acquisition and analysis
2. Process analysers
These measurements can be: at-line: Measurement where the sample is removed, isolated from, and analyzed in close proximity to the process stream. on-line: Measurement where the sample is diverted from the manufacturing process, and may be returned to the process stream. in-line: Measurement where the sample is not removed from the process stream and can be invasive or noninvasive
Identify and measure critical material and process attributes relating to product quality Design a process measurement system to allow real time or near real time (e.g., on-, in-, or at-line) monitoring of all critical attributes Design process controls that provide adjustments to ensure control of all critical attributes Develop mathematical relationships between product quality attributes and measurements of critical material and process attributes
Above is the basic concept of PAT tools on which guideline by FDA release in year 2004.
https://www.fda.gov/downloads/
Regards
Medipharma Official
