Analytical Method Transfer Approval and Use

[omviki]

Hi,

i am writing a method tranfer protocol to transfer hplc method to the outside contrace laboratory. i am also revising an SOP#xyz of analytical method transfer also beacause lots of thing in that sop does not make sense.

my question is should i revise and have it approved method the method transferSOP then have everyone signed method tranfer protocol ? OR it really does not matter just mention in the mthod transfer report that method tranfer was executed using a revised method transfer sop revision 02.

Thanks

[Wes Bucey]

In Reply to Parent Post by omviki

Hi,

i am writing a method tranfer protocol to transfer hplc method to the outside contrace laboratory. i am also revising an SOP#xyz of analytical method transfer also beacause lots of thing in that sop does not make sense.

my question is should i revise and have it approved method the method transferSOP then have everyone signed method tranfer protocol ? OR it really does not matter just mention in the mthod transfer report that method tranfer was executed using a revised method transfer sop revision 02.

Thanks

Welcome to the Cove! Congratulations on your first post.

You should be aware things slow down quite a bit on weekends here at the Cove and your query may go unanswered for a day or so. Do not be discouraged. I will come back from time to time to check on the progress of this thread. If others do not come forward with a viable response, I will help you recast the question to get a more focused response.

I have cleaned up the typographical errors in your original thread title to make it easier for search engines to index it. YOU, however, should pay some attention to cleaning up the typos in your post as good practice for writing SOPs and protocols to make them clear, understandable, and easy to follow for the members of your own organization and the outsource laboratory and to eliminate opportunities for misunderstanding your intent.

[CarolX]

Can any give some input to the OP on this?

FYI - HPLC=High Performance Liquid Chromatography

[Wes Bucey]

In Reply to Parent Post by omviki

Hi,

i am writing a method tranfer protocol to transfer hplc method to the outside contrace laboratory. i am also revising an SOP#xyz of analytical method transfer also beacause lots of thing in that sop does not make sense.

my question is should i revise and have it approved method the method transferSOP then have everyone signed method tranfer protocol ? OR it really does not matter just mention in the mthod transfer report that method tranfer was executed using a revised method transfer sop revision 02.

Thanks

OK. Let's parse the OP's post to give what answers we can.

method tranfer protocol to transfer hplc method to the outside contrace laboratory.

means the organization is going to outsource a process to a contract laboratory.

i am also revising an SOP#xyz of analytical method transfer also beacause lots of thing in that sop does not make sense.

The OP is revising a Standard Operating Procedure for transferring an analytical method because "lots of thing in that sop does not make sense." This raises two questions (1) Do they not make sense ONLY to the OP? or (2) Have many commented the SOP is confusing?

To the OP, the heart of the post is

my question is should i revise and have it approved method the method transferSOP then have everyone signed method tranfer protocol ? OR it really does not matter just mention in the mthod transfer report that method tranfer was executed using a revised method transfer sop revision 02.

It seems to me the OP is unnecessarily confusing the issue by using the terms "protocol" and "SOP" for a process or document that is essentially the same thing - the method his organization wants members of the organization to follow when transferring a previously in-house process to an outside organization. In my opinion, the fact the process is "analytical" has nothing to do with the underlying concept of assuring the outside organization performs the process as well as or better than the original organization. This is really the crux of all outsourcing.

Obviously, details covering the transition from the original organization to the outsource have to be covered. (timing - when does one organization stop analyzing and the other begin? Is there an overlap? Who and how will the quality of the work performed by the outsource organization be assured? How deep do we dig into the outsource's supply chain to assure quality materials are used?)

I also wonder how many similar transfers of processes are accomplished by the OP's organization each year that a protocol or SOP for such transfer is necessary.

[curryassassin]

I may be able to shed some light here.
Our new cover has to transfer a method to the contract testing lab. They have an OP to describe the method transfer process. They also need a protocol (quality plan) for the transfer of the specific method to the contract lab. It may be that the OP says they need a protocol. If my interpretation is correct, then it would be useful for the contract lab to at least review the method transfer protocol (plan) in case they have any comments/questions. A signature from the contract lab on the protocol may indicate their acceptance of the protocol.
Just to confuse you, as a contract testing lab, we always prepare a method transfer plan and seek approval of that plan. We usually receive some form of plan from the client, but we are never asked to sign it. I guess, so long as both parties agree on the transfer plan, it may not be important who generated the plan.