Dear all,
API manufacturing, multiproduct equipment.
The question came up whether it was acceptable to do three cleaning validation runs with three different products or whether it was mandatory that the the three runs be done after manufacturing the same product.
The implication is that if we want to do three runs with one product (typically a worstcase), depending on production planning, say one campaign per year, it could take up to three years to have a valid cleaning procedure. And the three runs would not really be consecutive.
Doing three runs with three different products allows to have three consecutive cleanings according to the production plan. We would clean after the next three products, one of them hopefully a worst case.
An alternative is to interrupt the next campaign of a worst case two times to be able to clean three times. As one cleaning may take a week, management is understandably not very happy to go for this option.
Thanks for your comments.