Definition of PAT:
Process Analytical Technology is a system for designing, analyzing,
and controlling manufacturing processes through timely measurements
(i.e., during processing) of critical quality and performance
attributes of raw and in-process materials, to ensure final product
quality.
The term analytical in PAT is viewed broadly to include chemical,
physical, microbiological, mathematical, and risk analysis conducted in an
integrated manner.
The emphasis in PAT is on the manufacturing process to amplify the
basic premise of the current drug quality system: Quality cannot be tested
into products; it should be built-in or should be by design.
Scope: The scope of the PAT Focus group
will be on the consideration of PAT as a scientific discipline
(see definition of PAT above) for enhancing product and process understanding
and controlling of pharmaceutical manufacturing processes. This will
encompass applications of PAT in both the manufacturing and R&D environments
including but not limited to the following:
- Drug substance/API route development and manufacturing control
- Drug Product/Formulations and process development and manufacturing control
- Raw materials
- Excipients
- Biologicals
- Animal Health products
- Generic products
The Focus Group is concerned with PAT applied throughout the lifecycle of a
product including:
- R&D
- Scale-up
- Tech Transfer
- Commercial Manufacturing
- Also cases involving CRO's
The FG aims to consider the Regulatory, Academic and Industrial perspectives
of the ramifications and issues of PAT.
Mission Statement:
The mission of the Process Analytical Technology Focus Group is to provide
leadership in the area of Process Analytical Technology by:
- Providing an accessible forum for discussion across industry, regulatory agencies and academia for improved understanding, utilization and implementation of PAT.
- Specifically for exchanging emerging scientific and technical accomplishments and experiences and the latest regulatory information on PAT.
- Proactively presenting position statements for APQ and PT sections of the AAPS with regard to PAT issues
- Serving as a communication link between the AAPS Sections and IFPAC, ASTM, ISPE, and PDA on PAT activities
Thereby establishing a center of excellence in PAT for the APQ and PT sections of the AAPS. Vision for PATFG: In the future the AAPS PATFG aims to:
- Effectively communicate across Industry, Academia and regulatory groups, the technical advances, changes in regulatory viewpoint and new applications of PAT
- Perpetuate the concept of PAT at a scientific level by providing programming that brings examples of PAT into the public domain
- Impact industry standards for utilization of PAT in the Pharmaceutical Industry through programming and communications of the PATFG
- Catalyze opportunities to expand targeted academic support and collaborations on topics involving PAT
Goals for 2008:
- Programming Goals
- Organize an AAPS workshop in collaboration with the MSE section for 2Q 2009.
- Provide programming ideas in during the 2009 annual meeting jamboree meeting in Aug 2008.
- Develop potential programming for 2009 in the form of workshops or evening meetings etc.
- PAT FG Website Update
- Provide initial website update by July 2008.
- Complete website update by October 2008.
Focus Group Activities
Meeting Minutes
Links of Interest
More links to be added. Members, please send useful links to listserve!
FDA, CDER PAT Webpage
http://www.fda.gov/cder/ops/pat.htm
ASTM Committee 55 on Pharmaceutical Application of Process Analytical Technology
http://www.astm.org/cgi-bin/SoftCart.exe/COMMIT/COMMITTEE/E55.htm?L+mystore+
The Journal of Process Analytical Technology
http://www.patjournal.com
JOIN THE PATFG FOCUS GROUP
To join the Process Analytical Technology Focus Group, click here.
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