Benastrum

In October 2006, the FDA released the OOS final guidance document titled “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production”. This document provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits. Due to controversies and much discussion, this new guidance replaced the draft guidance from September 1998, which was one of the most important guidance documents followed by FDA Investigators and Industry peers.

During this 2 hour presentation, Lic. Johnny Guerra will address the requirements for investigating OOS results in the laboratory area, including responsibilities of the analyst and supervisor, as well as the extension of the investigation to manufacturing processes and raw materials. The presentation will also discuss the interpretation of investigational results and a firm’s Quality Control Unit responsibilities when concluding the investigation process.

Discussion points include:

• An overview of the final FDA guidance document
• What FDA Auditors look for in terms of human errors
• The responsibilities of laboratory analysts and supervisors
• When the validation of the analytical method should be evaluated
• When a full investigation should be triggered
• Types of required tests to determine the validity of the OOS
• When and how often to conduct re-testing and re-sampling
• Assessing the product impact when documenting out-of-trend (OOT) results
• The essence of corrective and preventive actions plans (CAPA)