Prospective Validation.- Types of process Validation

- Prospective validation is one of the important type of process validation.

-This approach is experimental approach which performed for new process.

- Prospective validation is carried out during the development stage by means risk analysis  of the production process,which is broken  down into individual steps.

- Prospective validation performed on process should be completed before the commercial distribution of the final drug product manufactured from that API.

-  In prospective process validation following activities are involved.

   Determine the critical parameters.
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Determine the criticality of these factors

(where possible critical situations are identified)

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Produce series of batches using with the defined process The trials are then performed and evaluated, and an overall assessment is made. Performed extensive sampling and testing on the product at various stages & documented

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Minimum 03 consecutive batches shall be manufactured within predetermined parameters, Ensure that product manufactured by process is desired quality would constitute a proper validation of the process. If, at the end, the results are acceptable, the process is satisfactory.

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Upon completion of the review, recommendations should be made on the extent of monitoring and the in-process controls necessary for routine production Unsatisfactory processes must be modified and improved until a validation exercise proves them to be satisfactory.
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This form of validation is essential in order to reduce the risk of errors occurring on the production scale