Okay....I need some information. I've read the USP/BP/EP and ICH guidelines. I've read through Textbooks/Notebooks...I'm even ready to try matchbooks! I can't seem to find any specifics on what one should examine/inlcude when writing/conducting a method transfer to a quality lab.

So, the development and validation is done. Now what....transfer the method. However, there is no specific criteria (specific or general) which can be used as a guide for writing such a study. Does anyone know of a reference/website which can elaborate further on transfer specifics?

Other than using common sense in designing a transfer, there should be some sort of starting point. Can SOMEONE please help.

There is no starting point that I know about. Most pharm companies have SOP's on method transfer. Remember that what is trying to be deterrmined is if the lab can perform the test. The method's ruggedness should already have been proven during the validation. A good place to start may be the analysis of a sample already analyzed and a full report from the lab listing system suitability results and all peak areas, resolution, etc. It is really up to you, but you should be prepared to defend it to some unnamed governmental inspectors.

Hope this helped.

Chris

Don't forget operator training and related SOPs.

There is a lot of information in www.fda.gov. The
requirements for the transfer of analytical
methodology to the FDA are addressed in "Guidance
for Industry" dealing with CMC documentation
(www.verity.fda.gov/search97cgi).
In general, a Transfer Protocol describes the
elements necessary for an acceptable transfer of a
validated method to another laboratory e.g. from a
method development lab to an end user. The
elements usually are; (I) a written description of
the method (2) an interlaboratory collaborative
study (3) a summary report of the results of the
interlaboratory collaborative study and (4)
issuance the method as a control document. Using a
chromatographic method as an example and
addressing each in order:
(1) A description of; (a) equipment {actual
manufacturer} including column parameters (type,
dimensions, i.d.), (b) reagents. (c) operating
parameters (flow rates, gradients/ramps etc.), (d)
retention times to be expected (e) a step by step
procedure including the preparation of
samples/standards, (f) system suitability
requirements, (g) calculations and reporting of
results (ppm, wt % etc.)
(2) Submission of drug substance/product and
reference standards to end user laboratories for
collaborative analysis.
(3) Statistical comparison of data from
collaborative analysis showing results obtained
from different labs, days, analysts, and equipment
(i.e. ruggedness)
Summary report to management for acceptance as an
official company procedure