PharmTech Poll Results: How do you define 'PAT'? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

PharmTech Poll Results: How do you define 'PAT'?


Untitled Document

PharmTech Poll Results: How do you define ‘PAT,’ or ‘Process Analytical Technology’?

Thanks to all of you who participated in our poll! Here are a few of your answers, followed by the definition of ‘process analytical technology ’ given by FDA.

Your answers

1. “I believe that PAT is well-defined in their Guidance document in IV. PAT Framework, ‘a system for designing, analyzing, and controlling manufacturing ... with the goal of assuring final product quality. Analyzing is not just lab analysis but also includes statistical analysis of the data.’”

2. “PAT means incorporating analytical steps into each stage of the manufacturing process and using the results to evaluate and control the process in real time.”

According to FDA

FDA defines process analytical technology in its Guidance for Industry, as:

“Process Analytical Technology is: a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.  

“It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.” The guidance is available here.

To add your definition, click here.

Click here to visit our poll archive.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
10%
Provide treatment for patients globally.
6%
All of the above.
42%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Click here