Description

This Standard Operating Procedure (SOP) defines the mandatory process for identifying, documenting, evaluating, investigating, and closing any unplanned events, incidents, or deviations that occur during pharmaceutical manufacturing, packaging, testing, storage, or distribution.

The primary objective of this SOP is to ensure that any departure from established procedures, protocols, or Good Manufacturing Practices (GMP) is systematically evaluated to protect product quality, safety, efficacy, and patient health.