What is the practical difference between concurrent and prospective validation?
Is it just the fact that I cannot release & distribute the batch before the validation is finished (in prospective val.)?
In prospective validation we are optimizing the parameters whereas in concurrent one we are validating the optimized parameter.
Amit;):o
prospective validation is to optimize the validation parameters and to validate those parameters is the concurrent validation
PROSPECTIVE PROCESS VALIDATION is validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product’s characteristics.
CONCURRENT PROCESS VALIDATION is establishing a documented evidence that a process does what it purports to do based on information generated during actual implementation of process. Concurrent validation is performed when the frequency of manufacture is insufficient to satisfy prospective validation requirements.Batches may be individually released provided there should be sufficient assurance that each batch was thoroughly monitored and tested.
Concurrent validation may be conducted when data from replicate production runs are unavailable because only a limited number of Finished Product (FP) batches have been produced or FP batches are produced infrequently. Prior to the completion of concurrent validation, batches may be released for commercial distribution based on thorough monitoring and testing of the FP batches.
Also, when the prospective process validation is completed, any batches produced with a minor modification of that validated process can be released concurrently. (like if the compression machine is changed, then only compression cycle needs to be validated).
How can to validation robussness of the Manufacturing process.
Can you explain me.
Thank
So, what this means, if you perform prospective validation and there are modifications, you still have to perform concurrent validation (3 runs), with optimised parameters.
or you can access the impact of these changes and conclude the validation.
Jay