Method Validation or Verification

[VJ]

Hi

A company from Europ is supplying API to my company with all HPLC methods which are fully validated.
What should i should Do
1) Develop a new method by modifiying API Supplier's method ?
----> if i do not modify then how much validation work i need to do ?
2) Full method validation or partial ?
3) Method Varification ?
4) Method Transfer ?- i don't think so
4) Just use API Supplier method "as is " (no method development OR no validation needed) ?

My company is going to give have a contract with XYZ company to manufacture Finished Product. In this case i believe i do not need to do API Method development/validation at my compay because XYZ company will receive API from Europe so XYZ company should to API Method validation or varification.

Thanks

[LC_labrat]

I would read their validation first, hopefully they are willing to let you have it. If it meets your needs then why do all the extra work? You could do a pseudo method transfer, verifying their CofA results using their methods but run at your company. But then again I work in research, I don't have to follow all the regulations.

[Consumer Products Guy]

The way I understand things (which is proabably not correct) is that the API supplier must run all USP tests or validated tests on their API. Your location would need to assay the APIitself to make sure the API meets your raw material specifications, then assay the finished product for API level using a validated procedure (which may be completely different than that used for the API itself). So it sounds to me that you may need to validate a procedure for the API determination in the finished product. If the same test procedure is used as for the aPI itself, you may only need to verify that the test procedure applies to your finished product, a really gray area.

You do not need to repeat all the USP tests on the API, but those tests need to be transfered with a protocol to your location, such as comparing results for three lots. I'm sure someone will correct my thinking.

[Alfred88]

If the method is official, i.e. listed in USP/NF, then you may need to do a short 'method verification,' to show that it will work in your facility.

If the method was developed in-house, and not officially listed in USP, you may need to do an abbreviated validation, in particular system suitability. You may need to compare test results acquired by both facilities. This is more work than above.

Alfred.

[VJ]

Alfred88
what if i slightly modify in-house api method (supllier's method) like coumn and mobile phase composition. do i need to do a full validation or partial or verification?
thanks all of you guys for your help.

[JM]

VJ,

If Your API supplier has validated method , which you are going to use for release of their API at your formulation mfg plant . You need to "qualify" API vendor method at your lab ( mini validation parameter varification)). If the API supplier is your sister company , do the direct or indirect method transfer.

Some regulatory agencies may insists to carryout full API method validation even your vendor has a DMF or COS, why ? dont ask !!!

If you are changing their method you have to go for full validation and if it is only "tweeking" do method comarision and done with it.

This is how we do it for regulated markets.

JM