Chromatography Forum

Dear All,

ours is a API plant, at present R&D is planning to take process validation batches in labfor the first time. Now my query, is it compulasory to have analytical method validations in place, before performing the analysis of process validation of R&D samples.

In case i do the method validation after process validation, can i take any of these batches as working standard in the method validation.

rgds
...

Hi

See §12 ICH Q7a. Quite clear once procdation for commercial use is started, validation of analytical procedures needs to be completed as per ICH Q2. For inpsrocess controls full ICH Q2 rewuirements may not apply dpending on stange in process (see mentioned guidelines).

As for reference standards: AS per above you need to use previous smaller scale batches to create primary and/or secondardy references forr validation batches. After process validation these batches can be used to be qualified as secondary reference standards if needed.

Process validation samples must be tested with a validated assay (for active). Basically anything that will be released for sale must have everything done already. If the batch will not be sold, you may be able to use the data...not sure though, maybe if you can demonstrate that the same method is the one being validated at a later stage. I'm not sure.

On another note, I know many times here we have had to let process validation samples sit for a while before testing due to low resources (namely, manpower to test them). And it has not been an issue. So you may be able to put them on hold, validate the method, and then test them.