OOS
Verification of OOS Results | EDQM Guidelines
VERIFICATION OF INITIAL OUT-OF-SPECIFICATION RESULTS SCOPE The objective of this Annex is to describe the steps to follow for the management of out-of-specification (OOS) testing results. The failure investigation may also be triggered if validation criteria defined by the method or laboratory are not met, including out-of-trend (OOT) results. To ... Read More
Difference Between OOS and Deviation
OOS (Out of Specification) and deviation are terms commonly used in the context of quality management, particularly in pharmaceuticals industries. Here’s a brief overview of each term: Out of Specification (OOS) Definition: An OOS result occurs when the test results of a sample fall outside the established acceptance criteria or ... Read More
Difference Between Out of Specification (OOS) and Out of Trend (OOT)
OOS and OOT are two common terms in pharmaceutical quality control laboratory. In this article we mention the similarities and differences between Out of Specifications (OOS) and Out of Trend (OOT) Similarities between Out of Specifications (OOS) and Out of Trend (OOT) a. Both OOS and OOT are conducted in ... Read More