hey
just wanna know if we have not undergone any validation till now for product and the product is already marketed then what validation should be done and is concurrent pre-market validation?
I would say validate the process as per the manufactured product and leverage. If the validation fails, need to recall product.
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But what will be the type of validation
as i know concurrent is pre-market so retrospective ?
Mil, i dont have much experience. But as per knowledge, this is what i know: Equipment (manufacturing- Packaging) needed to validated, cleaning needed to be validated, and finally Process need to be Validated. QC test methods need to be in place to test everything. Patient safety is first thing. Cant market the bad stuff right? During development studies, companies come up with process parameters right, so mostly process wont fail. But sometimes when manufacturing large batch or operator faults or equipment failures would cause assay fails. So all these need to be validated. Which shows objective evidence to market the stuff.
I have seen companies had FDA warnings for incomplete validations. FDA would give time to validate the stuff. So i think its retrospective.
Just wanted to make clear understanding here, is the process changed for the product marketed to present?
no the process is the same and trials are undergone during development stage but just not documented so wanted to get clear on which type of validation it is. Even i think its retrospective or we can opt for APQR of the product
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From the APIC, I found this," retrospective validation is not condoned by regulatory authorities. prospective Validation is the ideal method of validation. In situations where very few runs are manufactured in any given period and or a business decision has been taken to release the next material manufactured after cleaning based on a high level of the equipment (i.e., validation level) concurrent release of material material may take place."