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