Process analytical technology

This article is the second of a series of articles detailing the development of near-infrared (NIR) methods for solid dosage-form analysis. Experiments were conducted at the Duquesne University Center for Pharmaceutical Technology to demonstrate a method for developing and validating NIR models for the analysis of active pharmaceutical ingredient (API) content and hardness of a solid dosage form.

Although the pharmaceutical industry has pioneered information technology as a research and development tool, it has consistently lagged behind other industries in using technology to automate and streamline manufacturing processes.

The author describes the efforts of the standards committees to establish guidelines for Process analytical technology (PAT) implementation and the impact of the guidelines o­n the industry.

Technical innovation in pharmaceutical manufacturing has been relatively slow compared with that in drug R&D, with many methods used for process analysis remaining largely unchanged for decades. To address this problem and ensure the safety and efficacy of drug production, the FDA has developed process analytical technology guidelines for quality testing.