Out of Specification (OOS)

OOS refers to a test result that falls outside the established acceptance criteria or specifications set by regulatory bodies or internal guidelines.

Example:

A drug’s potency result is found to be 95%, but the specification range is 98-102%.

Implications:

Indicates a potential quality issue, requiring a formal investigation to determine the root cause and implement corrective and preventive actions (CAPA).

Use Case:

Used for batch release, stability testing, and quality control evaluations.


Related Topics:

Partition CoefficientDissociation ConstantsNausea and Vomiting
BioavailabilityBiotechnologyBioinformatics


Resource Person: Vrunda Thakurdesai

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