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Oos investigation form 2025

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The document is a Microbiology Out of Specification (OOS) Investigation and Report Form (Form 690), designed to evaluate and report instances where microbiological test results fall outside specified limits. It includes sections for product details, laboratory testing evaluations, technician observations, and retest protocols. The form aims to ensure thorough investigation and documentation of OOS results, including necessary follow-up actions such as retesting and root cause analysis.

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Click ‘Get Form’ to open it in the editor.
Begin with SECTION A, entering the Product or Sample Details. Fill in the Unique Identifier, Product Description, Batch Production Number (BPN), and other relevant fields.
In SECTION B, evaluate laboratory testing by selecting the Test Type and providing details such as the Name of Technician who performed the test and whether training records are complete.
Continue through PART B, answering questions regarding equipment used, calibration due dates, and verifying calculations. Provide comments where necessary.
In PART C, outline the Retest Protocol by indicating if retesting is required and documenting any additional testing purposes.
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What are common oos examples?

Common categories of OOS results include: Finished product testing failures: These are among the most critical types of OOS results as they pertain to the final product intended for market release. An example would be an assay result indicating only 85% potency when the specification calls for a minimum of 90%.

How to properly investigate oos results?

A typical OOS investigation process covers the following: Definition of the problem or event. Examining trends and history. Risk assessment to understand the impact of the Out of Specification (OOS) on the final product. Prevent a recurrence of the problem. Identify the root cause through a thorough analysis.

What is phase 1 and phase 2 investigation in OOS?

In Phase I investigation, the focus is to eliminate laboratory error as a cause. The investigation progresses to Phase II when the cause is not a laboratory error, and a thorough investigation is undertaken to identify the causes in the production/manufacturing process.

What is an OOS investigation?

An Out of Specification (OOS) occurs when a test fails to meet acceptance criteria. An OOS Investigation follows an OOS test result and is performed to determine if there is a root cause. In this article we will look specifically at potential causes of potency OOS results of finished drug products.

What does oos mean?

OOS is an acronym most commonly meaning out of stock. In some cases it can also be out of service.