Method Development

[lusi]

Hello,
Can someone tell me how long does it takes to validate a published (some validated method) methods on a lab's GC MS?
Thanks

[Consumer Products Guy]

Why do you need to validate an already-validated test procedure?

Are you modifying the test procedure in any way? Validation of a test procedure is to ensure that it will work as performed.

[lusi]

Yes. In some cases, we are going to be using different column dimensions and flow rates. Also our lab instruments are different brand and in some cases different specs. from the ones we found methods developed for.

I got the impression that each method must be validated on the specific instrument. Is this true?

[chromatographer1]

The method should be qualified, not validated, if the instrument differs from the method's instrument.

Usually a method has within its validation multiple instruments, but often they are of the design design and company manufacturer.

Operators must also be qualified, to demonstrate they can perform the method.

Good luck,

Rod

[lusi]

Thanks Rod. But can you explain exactly what you mean by qualified?

[chromatographer1]

Most validated methods of companies following governmental guidelines state that the operator of the method must have the professional skills that meet the requirements of the technique of the method. That is not the exact wording but they convey the meaning of the requirement.

For example, it an operator did not have the skill to accurately measure out a volume of liquid accurately, or have the skill to cap a headspace vial so it seals properly, then how could they use the method or technique to execute the method as it is intended to be used, or how could the measurement of the method be considered accurate?

I had three operators qualified to use the methods I developed for a large pharmaceutical company, for whom I was employed.

best wishes,

Rod

[lusi]

Thanks Rod.

[martsims]

Validation procedures for methods in the pharma industry are typically nothing to do with the capabilities of the operator, but rather with the method. Check ICH Q2 for guidance.

[lusi]

Thanks martsims. Do you know about pesticides?

[Consumer Products Guy]

Thanks martsims. Do you know about pesticides?

Pesticidestest method validation fall under GLP/EPA in the US, not under cGMP. The validation procedures are similar but are definitely different in some areas. I've developed and validated test procedures for pesticides under GLP, and for pharmaceutical actives under cGMP.

There is USP and similar documentation that permits changes in column length, flow rate, temperature, etc., without having to re-validate. See USP <621>

[lusi]

Thanks Consumer Products Guy