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dp_for_verification_of_examination_methods [2025/01/30 04:18] – created admindp_for_verification_of_examination_methods [2025/01/30 04:22] (current) – admin
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-             Documentary Procedure for Validation & Verification of  examination methods+[[clinical_biochemistry_section|Home]] 
 +         Documentary Procedure for Validation & Verification of  examination methods
 **Purpose:** Method validation is an important requirement in the practice of an analytical process. One can interpret method validation as the process of defining an analytical requirement, and confirming that the method under consideration has performance capabilities consistent with what the application requires. If the result of a test cannot be trusted then it has little value and the test might as well have not been carried out. Therefore a laboratory and its staff have a clear responsibility to justify that the analytical part of the problem is correct, in other words results have demonstrable “fitness for purpose”. **Purpose:** Method validation is an important requirement in the practice of an analytical process. One can interpret method validation as the process of defining an analytical requirement, and confirming that the method under consideration has performance capabilities consistent with what the application requires. If the result of a test cannot be trusted then it has little value and the test might as well have not been carried out. Therefore a laboratory and its staff have a clear responsibility to justify that the analytical part of the problem is correct, in other words results have demonstrable “fitness for purpose”.
  
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 Precision (in this case meaning Repeatability) is usually stated in terms of Standard Deviation. Perform 10 determinations calculating the standard deviation at 3 concentrations (low, medium and high) Precision (in this case meaning Repeatability) is usually stated in terms of Standard Deviation. Perform 10 determinations calculating the standard deviation at 3 concentrations (low, medium and high)
  
-  * Limit of Detection (LoD) +  * **Limit of Detection (LoD)** 
-  * Limit of Quantitation (LoQ) +  * **Limit of Quantitation (LoQ)** 
-  * Linearity +  * **Linearity** 
-  * Carryover+  * ** Carryover**
  
 ^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^ ^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^
-^Document No.1^**Document Name**: Glucose Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^+^Document No.1^**Document Name**: Documentary Procedure for Validation & Verification of  examination methods^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^
 ^Issue No. : 01^Issue Date :30/04/2024^Page No.^^ ^Issue No. : 01^Issue Date :30/04/2024^Page No.^^
 ^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD,Biochemistry^ ^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD,Biochemistry^