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 ...

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, ...

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 ...

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 ...