Methods Validation

[Consumer Products Guy]

OK, most of the observers here know I am not enamored with my company's QA department. My questions are: (1) do your companies have separate Methods Validation departments, or is that responsibility of the Analytical Chemistry department who develops the test procedure? Unfortunately, I've only worked at one company, so don't know how most others do it. But I've heard of separate Methods Validation departments. (2) And shouldn't QA do the legwork for test method transfer? (3) Does GLP actually require RE-VALIDATION of the science involved, or just verifying that your existing validated test procedure applies to your new, similar formulation?

[DR]

Here, the department in charge of developing methods also writes the validation protocols. They then argue w/ the validations group about who will do what portions. Transfers to other sites are pretty much the Validation group's job (pretty much just a 2-lab repeat of intermediate precision or ruggedness portions of the original protocol w/ a fresh sample pool).

The validation group then writes protocol & transfer reports.

[gcguy]

My team do the method development and validation. When we transfer the methods into our QC department we also supervise the tech transfer, which is a slimmed down version of the validation. There are never any major issues with the transfer as we use Agilent kit in both labs. We are also reponsible for any training issues associated with the new methods.

GCguy