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Abstract:
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Process Validation is the evaluation of collected data throughout the design, manufacturing and commercialization of a product in order to confirm the capability of a process to output products of a pre-determined quality. Each manufacturer should confirm whether it has established sufficient scientific understanding to provide a high degree of assurance in its manufacturing process to justify release of the product. Hence a process validation lifecycle linking three crucial stages i.e. Design, Process Performance Qualification (PPQ) and Continued Process Verification (CPV). During Stage 2 PPQ, the process is verified using sampled data to demonstrate consistency. Thus, sampling plan/strategy, especially the number of required batches and/or samples within a batch, plays a key role in the decision making. The current FDA guidance on process validation relaxed the traditional three-batch validation assumption. Neither does it prescribe the number of validation batches needed for a validation nor a specific approach to use. In most cases there exist historical data about the process performance. Hence, techniques are needed to synthesize and leverage this information on process param
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