Chromatography Forum

When Transferring an in-house API Residual Solvents GC (non-compendial) method validated at an expert lab to a new third party lab and the option of transfer from the expert lab is not available, is it allowable to 'verify' the method at the 3rd party lab or should it be re-validated at the new lab?

1. We developed and validated cGMP test methods for our own finished products, to be used at both R&D, manufacturing QC, and contract manufacturing sites.

2. Never did we do a re-validation at a manufacturing QC or contract manufacturing site.

3. Validation is to establish that the science is good, robust, etc. Good science doesn't care where the procedure is performed, if it's a scientifically-good procedure.

How did you qualify the contract laboratories? Through Transfer? Bear in mind I don't have access to the expert lab to provide comparative data so that is why I think re-validation could be a good option.

Do you recommend I verify the method? Also to note this is an in-house method not pharmacopeial.

How did you qualify the contract laboratories? Through Transfer? Bear in mind I don't have access to the expert lab to provide comparative data so that is why I think re-validation could be a good option.

Do you recommend I verify the method? Also to note this is an in-house method not pharmacopeial.

If the science of your method is sound (correctly validated), then the science is sound. Obviously the test procedure must be written so there is no chance of a contract lab tech misinterpreting something. So we always did test method transfer; results on blinded samples provided by R&D (low, target, and high) had to be prepared and assayed by each analyst, with results sent to R&D for evaluation; that included checking the chromatography too.

Yes, we wrote SOPs for this...

So-called official methods are often terrible or the worst-written. It's like they're trying to save on ink....

How did you qualify the contract laboratories? Through Transfer? Bear in mind I don't have access to the expert lab to provide comparative data so that is why I think re-validation could be a good option.

Do you recommend I verify the method? Also to note this is an in-house method not pharmacopeial.

If the science of your method is sound (correctly validated), then the science is sound. Obviously the test procedure must be written so there is no chance of a contract lab tech misinterpreting something. So we always did test method transfer; results on blinded samples provided by R&D (low, target, and high) had to be prepared and assayed by each analyst, with results sent to R&D for evaluation; that included checking the chromatography too.

Yes, we wrote SOPs for this...

So-called official methods are often terrible or the worst-written. It's like they're trying to save on ink....

What parameters and acceptance criteria were applied?

This is what we did back then:

Three samples provided by R&D will each be analyzed for active level in full triplicate (triplicate weighings of each, at least two injections for each weighing) using supplied validated test method

1. For the samples, the average results of the two laboratories had to agree within 5%.

2. Success was defined when that agreement is reached (all three samples also within agreement).

3. Each potential operator must complete this validation to be considered qualified, or obtain similar results as a validated operator.

1. We developed and validated cGMP test methods for our own finished products, to be used at both R&D, manufacturing QC, and contract manufacturing sites.

2. Never did we do a re-validation at a manufacturing QC or contract manufacturing site.

3. Validation is to establish that the science is good, robust, etc. Good science doesn't care where the procedure is performed, if it's a scientifically-good procedure.

Yes but I don't have access to the lab at the site that validated the method. Just have their material and now have to qualify the receiving lab. In this instance should I validate at receiving site as the sending site can't generate comparative results?

In that instance, I'd consult with my QA department, and have them approve a contingency plan where carefully prepared placebo samples were fortified at 80, 100, and 120% of target, and then assayed at the new lab.

Not so sure what else is an option.