what’s the meaning of concurrent validation
The definition below is as per FDA guidance
Prospective validation is conducted before a new product is released for distribution or, where the revisions may affect the product’s characteristics, before a product made under a revised manufacturing process is released for distribution.[/color]
[COLOR=“blue”][b]Concurrent validation is a subset of prospective validation and is conducted with the intention of ultimately distributing product manufactured during the validation study. Concurrent validation is feasible when nondestructive testing is adequate to verify that products meet predetermined specifications and quality attributes. If concurrent validation is being conducted as the initial validation of a new process or a process which has been modified, product should be withheld from distribution until all data and results of the validation study have been reviewed, and it has been determined that the process has been adequately validated.
Concurrent validation may be conducted on a previously validated process to confirm that the process is validated. If there have been no changes to the process and no indications that the process is not operating in a state of control, product could be released for distribution before revalidation of the process is completed. There is some risk to early release of product in that subsequent analysis of data may show that the process is not validated.[/b][/color]
thank you for this valuable information