Hi, I would like to know when can one use the matrixing approach in process validation?
I have a scenario where I have two products with the same formula and manufacturing process using the same manufacturing equipment. The only difference with these products is the Active Pharmaceutical Ingredient (API).
The one has three API’s and the other has four API’s. Can one matrix these two products? If no, why? and If yes, why? Is there a guideline to matrixing in Process Validation?
Hi Ricardo,
You have mentioned that you have two products with same manufacturing formula and are being manufactured using same equipments. But the manufacturing formula is different wherein one product has three API’s and the other product had four API’s.These two products would be considered as entirely different products since the label claim is different.
Bracketting/Matrixing design can be applied to products with same formula, process, equipments but differing in strengths. The strengths may be different but has to be dose propotionate. eg.
Tablet Product A - x = 100 mg, y = 50 mg and z = 10 mg…avg wt = approx 300 mg
Tablet Product B - x = 50 mg, y = 25 mg and z = 5 mg… avg wt. = approx 150 mg
OR
Tablet Product A - x = 5 mg
Tablet Product B - x = 10 mg
Tablet Product C - x = 20 mg
The same blend can be compressed with different average weights producing three different products with different strengts. (but same formula).
I haven’t come across any guideline specifying matrixing in process validation for two different products.
Hope this info will help you.
Rajinder
I agree fully with Rajinder. There are very few cases where it is possible to matrix products for process validation. To my knowledge there is no guideline for this issue, but, as a hint, we are currently using the SUPAC guidelines as a decision aid to decide whether to revalidate a process partially (level 1) or completely (> level 1), so perhaps you could use this approach to reduce the validation workload.
Best regards
Alfred