Ive been doing work to validate a chlorphenamine tablet. Since it werent any info about the process, it started from ground zero.
So I ran tests for mixing (time of mixing and how the compounds were added), tableting (producing tablets at upper and lower quality limits, and also tablets at diferent weight and thickness parameters to test the press performance) and packaging.
So, just after I finished the validation studies, the R&D department got the notice that the manufacturer of the chlorphenamine isnt going to make it anymore, so they have to make new stability test for the active from another manufacturer.
The question is: Do I need to perform all the tests from the previous validation with the new manufacturer´s active, or just recopilate the needed info from the normal process, or there is no need of further test?
Ive been doing work to validate a chlorphenamine tablet. Since it werent any info about the process, it started from ground zero.
So I ran tests for mixing (time of mixing and how the compounds were added), tableting (producing tablets at upper and lower quality limits, and also tablets at diferent weight and thickness parameters to test the press performance) and packaging.
So, just after I finished the validation studies, the R&D department got the notice that the manufacturer of the chlorphenamine isnt going to make it anymore, so they have to make new stability test for the active from another manufacturer.
The question is: Do I need to perform all the tests from the previous validation with the new manufacturer´s active, or just recopilate the needed info from the normal process, or there is no need of further test?
Thanks in advance.[/quote]
Dear AiC,
it is not new that after a lot of pre-validation (and validation) work, the process is changed, the formula is changed, or the product is simply divested.
I don´t think there are universal criteria to decide whether to repeat the whole job or not. In your case, i would try to get as much information as possible regarding the physicochemical properties of the chlorpheniramine, both from the old and the new manufacturer, evaluate case by case the impact on the parameters you have determined, and perform a risk assessment of the change. Obviously the stability has a high risk of impact because the impurity profile depends on the synthesis route, but at a first sight, with a proportion in the formula of (my assumption) 1% of a water soluble drug, there should not be too many pharmacotechnical nor dissolution issues.