What is an "Out of Specification" (OOS) result?

An "Out of Specification" (OOS) result refers to a test result that does not meet the pre-established acceptance criteria for a given product or process. This definition is pivotal in the pharmaceutical industry, particularly concerning Good Manufacturing Practices (GMP), as it highlights instances where a product may not conform to its necessary quality standards.

The identification of an OOS result prompts a thorough investigation to determine the cause, which may involve reviewing testing procedures, equipment calibration, and sampling techniques. Addressing OOS results is crucial for ensuring patient safety and maintaining product integrity.

In contrast, other options relate either to satisfactory results or specific types of failures that do not encompass the broader definition of OOS results. Understanding these distinctions is essential for achieving compliance and ensuring the highest quality in pharmaceutical manufacturing.