Now a day’s regulators looking for control on the product /system recipe. Recipes are very critical part of process. Because process are control through validated recipe. If firm calming that their system complying 21 CFR par 11/EU annex 11, in that case they should ensure that their system is capable for following mentioned control,
a) System should available with the audit trial and it should capture in case any change in individual recipe
b) Recipe edition, modification and deletion to be assign to only administrator, these mentioned options should not accessible to other authorization level.
Proper documentation should to be available to control recipe version. Each and every process recipe should to be validated through qualification program. Periodic batch data should to be store or archive in secure manner.
Software backup/image backup to be keep as a part of disaster recovery.
For example,
In case of any CIP (Clean in place) system, cleaning recipe should to be validated and it should to be save in the system HMI/MMI accordingly with the unique ID or product code. All parameters should to be validated and predefined in the system, like
· Soft water flushing timing
· CA air flushing/drying timing
· Purified water flushing timing
· No of rinse
· CA air flushing/drying timing
Don’t panic if organizations not complying 21 CFR part 11 /EU annex 11 requirements. Once the recipe is validated it should to be mentioned in the respective operating procedure or batch record. Before batch clearance respective recipe should to be check against the process and should to be documented as well. It need to be ensured recipe selected for the process are correct and validated.
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Hello, i read your blog occasionally and i own a similar one and i was just wondering if you get a lot of spam responses? If so how do you protect against it, any plugin or anything you can advise? I get so much lately it's driving me crazy so any help is very much appreciated.
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