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Quality Control01:05

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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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PAT for monitoring the state of control in continuous manufacturing of solid oral dosage forms.

Nathaly A Movilla-Meza1, Dhavalkumar S Patel1, Rafael Méndez2

  • 1Department of Chemistry, University of Puerto Rico at Mayaguez, PO Box 9000, Mayaguez, Puerto Rico, 00681, USA.

Analytical and Bioanalytical Chemistry
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Summary

Process analytical technology (PAT) ensures pharmaceutical manufacturing control. Near-infrared spectroscopy monitors drug concentration in continuous manufacturing, improving product quality and process reliability.

Keywords:
Continuous manufacturing (CM)PharmaceuticalProcess analytical technology (PAT)SamplingState of controlVariographic analysis

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Analytical Technology
  • Spectroscopy

Background:

  • Process analytical technology (PAT) is crucial for maintaining control in pharmaceutical manufacturing.
  • Continuous manufacturing offers advantages but requires robust monitoring.
  • Near-infrared spectroscopy (NIRS) is a key PAT tool for real-time analysis.

Purpose of the Study:

  • To review studies on PAT implementation in continuous pharmaceutical manufacturing.
  • To evaluate the performance of NIRS for drug concentration monitoring.
  • To highlight methods for improving PAT effectiveness and process understanding.

Main Methods:

  • Review of continuous manufacturing studies (up to 120 hours).
  • Application of near-infrared spectroscopy for drug concentration determination.
  • Validation of analytical methods (accuracy, precision, linearity, robustness).
  • Use of residence time distribution and variographic analysis.

Main Results:

  • NIRS effectively monitors drug concentration and product specifications.
  • Repeatability studies are vital for method performance.
  • Real-time monitoring is feasible from various sampling locations.
  • PAT and modeling enable detection and diversion of non-conforming material.

Conclusions:

  • PAT, particularly NIRS, enhances continuous manufacturing control and reliability.
  • Variographic analysis distinguishes process variability from errors.
  • Improved process understanding and product quality are achieved through PAT implementation.