Reference standard material critical reagents

Before an instrument is used to validate a method, its performance should be verified using generic standards [22,23], Satisfactory results for a method can only be obtained with well-performing equipment. Special attention should be paid to the equipment characteristics that are critical for the method. For example, if detection limit is critical for a specific method, the instrument s specification for baseline noise and for certain detectors also the response to specified compounds should be verified. Any material used to determine critical validation parameters, such as reagents and reference standards, should be checked for accurate composition and purity. 

Reagents and reference materials Likely will change but should have some documentation on early characterization Continue to screen for optimal reagents Lot no. and history (notebook reference) Evaluate different reagents and identify critical reagents Determine if sufficient quantities are available and their stability for later bioanalytical needs Include C of A for reference materials in assay validation documents Keep records of source and lot no. Use optimized capture/ detection reagents Use characterized reference standard from final manufacturing process with Cof A Record all lot nos. and sources... 

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