WHO has quoted “Cleaning procedures for products and processes which are very similar do not need to be individually validated” in its guidelines. Would somebody please explain me what the products very similar means. Does it means products of same classification, same product with different dosage form or content, different products having same properties or what else?
Similarly what the processes that are very similar means?
May I validate a cleaning procedure of a equipment like Double Cone Mixer by validating with a single product glimepiride (in my case) which is the most potent, practically insoluble in water (I am using water as cleaning agent) and having the lowest Maximum allowable residue in order to adresses the risks, solubility, MAR and potency of the drugs. Is single product enough for the equipment for validating the cleaning procedure effective for removing all worst case?
Moreover, what does the identical and interchangeable equipments. If I use double cone mixer for mixing instead of Rapid Mixer Granulator then are the double cone mixer and rapid mixer granulator are interchangeable?
Waiting for replies.