Causes of Out of Specification

Out-of-Specifications Deviations of products from pre-determined specifications. This means when a product is unable to meet the predetermined limit for that particular product. There are several possibilities that could account for this deviation. These possible reasons for out-of-specification can ...

Out of Specification Investigation

A recent report by the US Food and Drug Administration (FDA) showed an increase in investigations of off-specification products in the pharmaceutical industry. The FDA cites deterioration in quality control as a major cause of these problems. As the industry transitions to novel and more complex products, ...

SOP for Out of Specification (OOS)

1. Objective: This document describes the procedure for reporting, investigating, and documenting Out-of-Specification (OOS) laboratory test results. This document is also intended to help in determining the root cause and establishing appropriate corrective and preventive actions (CAPA) for laboratory ...

Benefits out of specification investigation

Off-specification investigations in pharmaceuticals have many advantages. Out-of-specification investigations can help identify product defects and manufacturing defects, which can lead to improved efficiency and quality control. Additionally, specifications can help identify potential new markets for ...
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