Bioequivalence and Bioavailability Forum

Hi Ken Peh,

❝ For bioanalytical method development, we are told to show where we get the method from and how we start until we get the method before method validation. How much documentation is sufficient ? Do we need to record all the steps, procedures and print out all the chromatograms as proof ?

I think there will be a lot of different views on this. Mine is, assuming you work under GLP when doing studies:
1. You can fiddle with a preliminary method without documenting much as long as it is not part of any GLP work. In my opinion, it is not GLP per se when you are at a stage when feasibility of the method is only being roughly assessed. You try different columns, chromatographic settings, room number XYZ16 etc etc and basically play around until there comes a time when you start the 'real' GLP work: method development, method validation, use of method.

2. At that time when the method development is about to take shape things get serious and all steps need to be regulated, documented and have traceability.
[I am aware that some CROs do not view method development as GLP work. I would play it safer than that; for instance, it can be argued that the SD does not know which ressources to allocate for method validation if the method development was not documented, traceable and regulated by SOPs.]
Record all steps? Yes.
Record all procedures? Yes (record may be the wrong word here - it is about having a written procedure for essential steps)
Print out all chromatograms? No not necessarily; if the chrom. sources are stored electronically and their parameters are controlled via audit trails, this will suffice. A printout may not be considered source data but rather a graphical representation of processed source data.

This is just my personal view. Unfortunately GLP leaves a lot for interpretation. For example chromatography isn't mentioned.