Process Analytical Technology (PAT)

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

1. Focus requirements on areas of manufacturing that pose greatest potential risk
2. Ensure that FDA quality standards do not impede innovation and introduction of new technology
3. 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 Process Analytical Technology 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 sits well with how the Insitec is implemented in process situations.

Why Process Analytical Technology?

The Process Analytical Technology framework provides:

• 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.

Insitec on-line particle size analyzers can help your pharmaceutical solution meet the Process Analytical Technology initiative.

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