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Name of Technician who performed the test Training records complete Date Sampled Date Test performed Was test conducted in accordance with SOP Media/Reagents Used If No comment Lot Number Expiry Date Passed QC Checks Date Printed File Location Page 1 of 3 PART B Equipment Used Calibration Due Date Temperature Trends in range Negative Controls passed Other tests from same test session within limits Other Sources of Error Technician observations during testing N/A Are Calculations Verified and co ...
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Checklist for OOS Investigation Analyst errors. Analysts must investigate for laboratory errors which can occur when analysts make analytical mistakes. ... Instrument/ Equipment Errors. ... Laboratory System Errors. ... Operator Error. ... Equipment Error. ... Production Control System Error.
13 The Agency also recommends that OOS investigation reports be provided to the customer. of a discrete test result may be done only upon the observation and documentation of a test event that can reasonably be determined to have caused the OOS result.
What Does OOS Mean? Out-of-Specification (OOS) means that the test results for your sample do not meet the accepted established criteria. These criteria may be set by either an official compendia, by your organization, or by the testing laboratory.
The hypothesis test plan should pre-define the expected criteria/results to prove or disprove a hypothesis. This should also include the scientific rationale or justification for such criteria. Within the test plan, generating data that meets material specifications does not necessarily confirm a root cause.
Checklist for OOS Investigation Analyst errors. Analysts must investigate for laboratory errors which can occur when analysts make analytical mistakes. ... Instrument/ Equipment Errors. ... Laboratory System Errors. ... Operator Error. ... Equipment Error. ... Production Control System Error.

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The OOS investigation involves 2 phases.
1. Investigating Out-of-Specification (OOS) Test Results. for Pharmaceutical Production. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
The OOS investigation involves 2 phases.
On observing an OOS result, a laboratory preliminary investigation (Phase-I) is recommended to identify the assignable cause. Based on the findings, further investigations will be conducted. If no error was found, then too, the batch may need a QA to be performed.
Checklist for OOS Investigation Analyst errors. Analysts must investigate for laboratory errors which can occur when analysts make analytical mistakes. ... Instrument/ Equipment Errors. ... Laboratory System Errors. ... Operator Error. ... Equipment Error. ... Production Control System Error.

Related links

Investigating Out-of-Specification (OOS) Test Results for ... - FDA

May 16, 2022 — This guidance for industry provides the Agency's current thinking on how to evaluate out-of- specification (OOS) test results.

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SCA Pharmaceuticals, Windsor, CT. 483 Issued 11/19/2019

For example: Out-of-Specification Laboratory Investigation Repo1t OOS 18-087-W was initiated on 10/15/2018 for the sterility test failure of Buffered ...

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SOP forout of specification - Academia.edu

Cross-reference of OOS investigation form shall be given in the analytical report. ... ___ Out-of-Specification Laboratory Test Result Investigation Report ...

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