Out of specification investigation flowchart for laboratory stage as well as manufacturing.
Out of specification results are not rare in pharmaceutical industries but their investigation and finding the real root cause is time consuming process and includes many steps.
Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable ...
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 ...