FOREIGN PARTICULATES (FOREIGN PARTICLES)

Control of particulate matter in manufacture of quality products is of critical importance. Both industry and FDA are taking great interest in using best approaches to the assessment and regulation of foreign particles in OINDP. Therefore IPAC-RS formed a Foreign Particles Working Group to address these issues. That work resulted in two publications, which lay the foundation for quality-by-design management of foreign particles:

• Foreign Particles Testing in Orally Inhaled and Nasal Drug Products in Pharmaceutical Research (Volume 21 Number 12 /December 2004).
• Best Practices for Managing Quality and Safety of Foreign Particles in Orally Inhaled and Nasal Drug Products, and an Evaluation of Clinical Relevance in in Pharmaceutical Research (Volume 24, Number 3 / March, 2007).