Validation of new supplier reagents

[bb1882]

Does anyone perform a validation when they receive FDA approved antisera (i.e. anti-E) from a new supplier?

[clmergen]

We only QC it on the day we use it to test. We do review the package insert to make sure that a change hasn't been made to the procedure.

[L106]

I think bb1882 is asking if we do validation (not just QC) the first time we receive a reagent from a new vendor/company.

[KKidd]

We don't do a validation for our antigen typing sera (due to limited supply). Otherwise we do perform a validation if we change suppliers. Recently we have switched from non-buffered saline to buffered and Immucor QC to Ortho. Validations were performed in both insances.

[tbostock]

It is recommended that you do a supplier qualification as well as a validation when using a reagent made by a new supplier.

[JHH1999]

I'm not sure how anyone could validate a blood grouping reagent from an end user standpoint or what would be the reasoning to perform such a monumental task on a reagent that is FDA licensed.

You can validate or qualify a piece of equipment and validate a process or method, but I do not believe using the term "validate" with a blood grouping reagent is appropriate.

Manufacturers are required as part of licensing to perform an enormous amount of testing (clinical trials) to enusre the reagent reacts as intended. The testing performed by any user would be minimal compared to what the manufacturer has already done. It would be a waste of valuable reagent and not add any value to test results.

If you follow the manufacturers test instructions properly and expected results are obtained each day with known postive and negative controls, test results are valid.

To meet Quality System requirements you should have a process to evaluate/qualify suppliers.

[Lcsmrz]

We blood bankers tend to use the term "validate" very loosely. Most of what we call do is not really validation at all, but everyone knows what we are talking about when we say that.

Obviously, I do not repeat lot-release studies when accepting a new shipment of a reagent. Nor do I repeat a clinical trial when changing vendors. But I also don't exchange reagents from different vendors as if they were interchangeable.

In addition to qualifying the vendor, I review the product insert, SOP and forms to see if any changes are required, then notify staff that we are changing vendors and that no modification is required for use. And of course, I document the decision.

[JHH1999]

I would agree with this approach on this subject. Hence, why as stated it is very important to review and follow manufacturers instructions if you want to obtain valid results.

Different manufacturers reagents may have different instructions based upon formulation more so now than ever with the arrival of so many monoclonal reagents instead of traditional polyclonals.

However, the methodology of these reagents is still the same. We are using antibody to detect the presence or absence of antigen on a red cell. The antigen typing using one reagent should be the same using another reagent unless there is some rare type of variant present.

Being in the blood bank world for 20 years now including the last 10 years in quality and validation of reagent manufacturing, I'd like to save folks what I see as unnecessary additional work and effort.

[Vic]

We don't do a validation for our antigen typing sera (due to limited supply). Otherwise we do perform a validation if we change suppliers. Recently we have switched from non-buffered saline to buffered and Immucor QC to Ortho. Validations were performed in both insances.

How exactly did you validate your saline? We are currently undergoing the same change and I am just wondering how you did yours.

[Eagle Eye]

decide # of specimen you will run. eg. 5--then run the tests where you would use saline using non buffered saline and buffered saline in parallel.