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.
Prawan Dahal
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.
Prawan Dahal
Dear Prawan
Please note that you have to select the worse case among the range of product being manufactured using a series of equipment including ancillary equipments. There can be very similar products or may be different products. WHO has classified therapeutic classes which totally needs seperate Mfg facility and utility even seperate material and personnel movements E.g. Ceph area. Even in Ceph area certain ceph products considered to be very similar, are manufactured using the same equipment train and a worse ceph product is selected for cleaning validation. Worse case selection should depend on High toxicity and low solubility criteria. So all products need not be validated a worse can represent the suitability and effectiveness of cleaning procedure.
[quote=Shahid Ali]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.
Prawan Dahal
Dear Prawan
Please note that you have to select the worse case among the range of product being manufactured using a series of equipment including ancillary equipments. There can be very similar products or may be different products. WHO has classified therapeutic classes which totally needs seperate Mfg facility and utility even seperate material and personnel movements E.g. Ceph area. Even in Ceph area certain ceph products considered to be very similar, are manufactured using the same equipment train and a worse ceph product is selected for cleaning validation. Worse case selection should depend on High toxicity and low solubility criteria. So all products need not be validated a worse can represent the suitability and effectiveness of cleaning procedure.[/quote]
Thanks Shahid Ali for your reply. For determining product with high toxicity, what should be considered, the dose of the product or LD50 of the active pharmaceutical ingredient. I think dose should be considered as LD50 should be considered onyl for the product which dose is unknown. Am I right?