In the pharmaceutical industry, “deviation” refers to any departure from approved processes, procedures, specifications, or expected outcomes. These deviations can occur during manufacturing, testing, packaging, or storage of pharmaceutical products. Managing deviations is critical to ensure product quality, safety, and regulatory compliance.
Types of Deviations in Pharma:
Planned Deviation: When a process needs to be temporarily altered with prior approval (e.g., using an alternative supplier for a short time).
Unplanned Deviation: Unexpected departures from procedures
