====SOP of Validation of new lot of reagents====


Objective:\\
To validate new lot of reagents before use\\ 

Requirement:\\
•	New lot\\
•	Validated lot in use\\
•	Testing sample\\

Procedure:\\
•	We validate every new batch of reagents by running the sample first with the old reagent and then re running it with new set of reagents and results are compared.\\
•	There should be positive linear regression(R squared - 0.5 to 1) between two lot.\\ 
•	Lot validation records of reagents are filed in respective instrument internal quality control records HI\Records\File\9\Internal QC records.\\
	

Stains:\\
•	In case of stains 2 slides are prepared from the sample at same time fixed and then stained with old stain as well as newly prepared stain.\\
•	The quality of slide staining is checked by senior resident.\\
•	Lot validation records of stains are maintained in separate registers. HI\Records\File\9\Internal QC records-J\\