I am working in analytical& development department of one GMP pharmaceutical company,in this company there are one separate department QC.My department belongs to products research&development dept. and not covered in GMP, while QC department is one important dept. of GMP system.
Do anyone can help to clarify that QC dept. should revalidate the analytical methods which have already developed and validated by my department or not?

Very thanks

If:
- you validated your methods according to appropriate specifications (generally, ICH) including inter-laboratory reproducibility AND
- you have documented the validation results to cGMP standards.

Then: there should be no need to revalidate the methods.

However, if your validation does not meet the criteria above, then the method should be revalidated before being used in a cGMP environment.

AnalyticalPerson,
Might I suggest that Anon above is absolutley correct but that you might talk with whomever is validating the methods and have the QC Dept. in on the validation process as part of the method ruggedness, they will be the "third" analyst. This helps with the method and with the method transfer, when QC gets ready to use the method routinely they will already be familiar with it.

Regards,
Mark

I wonder, though, that if analyticalperson's lab is officially classified as a non-GMP lab if anything coming from that lab can "become" GMP simply because it has been documented well. For example, are the instruments all calibrated with appropriate SOP's, etc. If so, then why is the lab not considered GMP? You are either a GMP lab, or you're not, and this classification goes far beyond the documentation. I can't see that validation work done in this environment can be considered GMP, even if all work, documentation etc. is up to cGMP standards. Are your co-workers and management prepared to have the entire lab operation audited for cGMP compliance because you want to use this validation data? If the chemist on the bench next to you isn't fully GMP, than you can't be.

I work at cGMP R&D at consumer products company with some OTC products. We develop and validate test methodologies here, then do a validated test method transfer to QC, including blinded samples. There is no need to re-validate the good science already documented, hard to break the laws of physics (or chemistry).

CP Guy- I agree thats since you work at a GMP site, there's no problem using your validation data in QC. If your department was not GMP, you would not be able to use that data in QC, regardless of how well the science was performed, without opening up your department's operations to the potential of a GMP-caliber audit.

I work in a Research and Development lab in a pharmaceutical company. Every method we develop in my division has to be revalidated in our QC department before they use it routinely, BUT using our validation protocol and analytical procedures. So basically QC has to re-validate every method that we transfer due to several reasons including the GMP issue and robustness issue.

Ananda

Ananda,

Absolutely there is no meaning in doing revalidation of the methods once you validated the method. If you validated the methods in any laboratory (with validated analytical equipments)
QC need not to re-validate the methods, unless other wise there is any change in the analytical method.

If a method has been developed and properly validated in a GMP lab, there is no requirement to revalidate in an other lab; however it is a good practice that the receiving lab formally documents the method transfer.
This documentation should examine weither any discrepancy between local set-up (instrument brand, type, configuration, software type, reagents grade ...) and validation conditions is already adressed in the validation file (mainly in ruggedness and robustness).
If not or partially, the transfer documentation should include validation complements (it is also a good practice that the receiving lab keeps the validation lab aware of these complements so as they are available for a future transfer in a third lab).