PDA Letter Article

Foreign Particles in Bull’s Eye of Global Reg Agencies

by Hirohito Katayama, PhD, Bayer Yakuhin, and John Shabushnig, PhD, Insight Pharma Consulting

Visual Inspection

A fill/finish process for injectable products must ensure that the formulation is accurately filled into the container (e.g.,ampoule, vial, syringe, bag). The container must also protect product throughout the shelf-life. The container should be free of foreign particles and sealed without dam-age that could affect container integrity.