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In prospective validation, the validation protocol is executed before the process is used commercially. The manufacturing process should be divided into separate steps during the product development phase. Each step should be evaluated based on experience or theoretical considerations to determine important parameters that may affect the quality of the finished product. A series of tests should be designed to determine the criticality of these factors. Each test should be planned and fully documented in an approved protocol.
All equipment, manufacturing environment and analytical test methods should be fully validated. Master batch documents can be prepared only after identifying important process parameters and determining machine settings, material properties and environmental conditions. It is generally considered acceptable that three consecutive batches/runs within ultimately agreed parameters, providing a product of the desired quality, will constitute a proper validation of the process. This is a confirmation of three batches of commercial before marketing.
After the review is completed, recommendations should be made regarding the amount of monitoring and in-process controls required for regular production. These should be included in batch production and packaging records or in appropriate standard operating procedures. Exceeding limits, frequency and steps should be specified.
It may be possible and acceptable in a given situation for a manufacturer to develop a scientifically sound validation plan for that process rather than a different plan for each product manufactured by that process using the same process for several related products.
Matrix methods typically mean planning to conduct process validation on different strengths of the same product, whereas “family” methods mean planning to conduct process validation of different products made with the same process using the same equipment.
The validation process using these methods must include batches of different energies or products selected to represent the worst-case scenario or scenarios that are consistent for all energies or products involved in the process.
