Chromatography Forum

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

That depends entirely on what your organization's policy is on revisions to SOPs.

^ right - if this is a "one off" kind of thing, it would probably be better to explain anticipated deviations form the SOP in the protocol and have someone from the SOP policing dept. (Quality) sign off on it as well.

Working in a regulatory background I would get your SOP in place first.

I would also avoid reference to "version numbers" in protocol texts. By all means cite SOP numbers or titles but the date of issue on the transfer protocol will identify the version of the SOP which should have been followed.

All staff involved in the transfer process should sign for :

Reading (and understanding) the SOP (usually documented in their training file).
Reading (and understanding) the Transfer Protocol (usually documented in the Transfer data.