Would it be gmp and fda compliant to manufacture and use an in house cleaning agent for a manufacturing area in a pharmacutical company,the formula is a concentrated alkaline solution with surfactants and a biocide,i am aware of the cleaning validation that would have to be done on worst case materials and equipment, the ld50s of the components of the formula and the specific and non specific tests of formula removal but what i am not sure about is what analyitical tests and methods need to be done on the actual formula before i introduce and am allowed to use it in a regulated area?
Has anyone any experience of companys making their own cleaning agents?
WHY would you want to use your own? Isn’t it cheaper and easier to purchase premade?
Secondly, to put it simply, you can use whatever you want. As long as a) It is effective b) has no effect on product c) no residual left d) harm to humans using it is mitigated by using proper personal protection
Regulatory Agencies and GMP don’t care about the economics of it all, if you wanna make your own (even though it MIGHT be more expensive), knock yourself out, just prove it’s safe to use, effective and has zero effect on product.
WHY would you want to use your own? Isn’t it cheaper and easier to purchase premade?
Secondly, to put it simply, you can use whatever you want. As long as a) It is effective b) has no effect on product c) no residual left d) harm to humans using it is mitigated by using proper personal protection
Regulatory Agencies and GMP don’t care about the economics of it all, if you wanna make your own (even though it MIGHT be more expensive), knock yourself out, just prove it’s safe to use, effective and has zero effect on product.[/quote]
Mr. Morphius is right, You can use whatever the cleani g agent use whether they claim FDA compliant or not but you have to challenge (validate) the effectiveness of agent, exposure time study, resuides study, effect of surfaces and products, safety and storage & holding studies. Please use common science and draw scienrtific study and validate cleaning agent whether it is in house agent or any FDA compliant agent.
-Stabiity–How Long(Shelf Life)? What Temperature?
-Storage Container-material of construction
-Using PW? Water for Injection?
-Concentrate? Dilute?
-Raw materials? You want to make sure the raw materials going in to make this in house recipe aren’t subpar to start with.