The FDA created the Process Analytical Technology (PAT) initiative to help ensure that quality standards do not impede innovation
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Process Analytical Technology (PAT)

Prevention is better than a cure

The FDA initiative to enhance current Good Manufacturing Practices (cGMPs) has three Major Goals:

Focus requirements on areas of manufacturing that pose greatest potential risk

Ensure that FDA quality standards do not impede innovation and introduction of new technology

Enhance consistency & predictability of FDAs quality assurance approach

21 August 2002, FDA-CDER created the Process Analytical Technology (PAT) initiative to address the second goal of cGMP enhancements, with a mandate to:

Identify candidate 'science-based' technologies for real-time analysis of physical properties and chemical composition.

Facilitate introduction of new technologies to the manufacturing sector of pharmaceutical manufacturing by remove real/perceived 'regulatory hurdles' .

Process Analytical Technology Framework

In the conceptual framework, the FDA recognizes unit operations using PAT extensively (on-line
sizing, on-line NIR etc) throughout as having an inherently lower risk ultimately to the patient than a process which relies on older manual infrequent measurement techniques.

Process Analytical Technology Framework

For on-line sizing, this conceptual framework sits well with how the Insitec is implemented in process situations.

Why Process Analytical Technology?

Process Analytical Technology Benefits

Greater insight and understanding of processes

At- / On- / In-line measurement of "performance" attributes

Real-time or rapid feedback controls (focus on prevention)

Potential for significant reduction in production (and development) cycle time

Minimize risks of poor process quality and reduce (regulatory) concerns

Process Analytical Technology and Particle Size Analysis

Laser diffraction is now the pharmaceutical standard for laboratory particle size analysis. With over 300 Insitec on-line sizers working world-wide, Malvern's process team has unparalleled experience in in-process particle size analysis.

Full product quality monitoring
"Every patient is special" - Monitor entire batch
Minimize batch-to-batch variation

Process Understanding
"Quality by design"
Reducing waste
Increased yields

Process Containment
Measuring toxic compounds
Keeping "clean rooms" clean
Minimizing operator exposure

Scalable Solution
From lab scale to full-scale production

Click here for more information on the pharmaceutical solution of Insitec on-line particle size analyzer.

 

 
For more information, visit the FDA Process Analytical Technology (PAT) initiative web site