Hi All,

I need information on the validation of the transfer of analytical HPLC methods between laboratories. Does anyone know of a protocol
for such method transfer validation?

Many thanks in advance for your help.

I know of no regulatory guidance on this topic, but articles have appeared from time to time in various trade magazines. Typically you want to ascertain that the receiving laboratory can execute the method with accuracy, and with variation no greater than the originating lab. Ideally the testing is conducted on the same lot of material in both labs, and an analysis of variance is made to verify equivalence. Should the labs prove inequivalent, you may want to launch an investigation. - Mary

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)
(4) Summary report to management for acceptance as
an offical company document

Dear Buglio:

I checked the link (www.verity.fda.gov/search97cgi) you gave. However, the web location has changed. Do you know where the document can be found on current FDA web site?

Thanks a lot in advance.

Dear Anon.
The site is inoperative probably because it was
being sent out "for comment purposes only" and has
now gone to the draft stage. As mentioned above,
this was a Guidance for Industry dealing with the
analytical methodology of a CMC section and
addressed the transfer of technology to the FDA.
The Draft Document seems to have the
address;www.fda.gov/cder/guidance/2396dft.pdf.
It’s not as detailed as the Transfer Protocol
above but does give a sense of what they are
looking for. The Protocol is a consensus from
several sources and will satisfy the requirements
noted in the FDA draft. For the status of this
Draft Document it would be best to contact the
author, R.Rajagopalan @ 301 827 5849.