Concurrent Validation- Types of Process Validation

- Concurrent validation is carried out during normal production.

-This method is effective only if the development stage has resulted in a proper understanding of the fundamentals of the process. 

-The first three production-scale batches must be monitored as comprehensively as possible. The nature and specifications of subsequent in-process and final tests are based on the evaluation of the results of such monitoring.

-This careful monitoring of the first three production batches.

-Concurrent validation together with a trend analysis including stability should be carried out to an appropriate extent throughout the life of the product.

-As per ICH guideline Concurrent validation can be conducted when data from replicate production runs are unavailable because only a limited number of API batches have been produced, API batches are produced infrequently, or API batches are produced by a validated process that has been modified.

-Prior to the completion of concurrent validation, batches can be released and used in final drug product for commercial distribution based on thorough monitoring and testing of the API batches.

-Concurrent validation may be the practical approach under certain circumstances. 

-when a previously validated process is being transferred to a third party contract manufacturer or to another manufacturing site.

When the number of batches produced is limited.

-When the number of lots evaluated under the Retrospective Validation were not sufficient to obtain a high degree of assurance demonstrating that the process is fully under control.

- Concurrent Validation is most widely used to validation of the manufacturing process in Pharma.