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
JOIN THE PATFG FOCUS GROUP
To join the Process Analytical Technology Focus Group, click
here.
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