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| Since 2011 the fda prescribes a lifecycle approach to process validation, consisting of three stages stage 1 process design, stage 2 process performance qualification ppq, and stage 3 continued process verification over the lifecycle of the process and product. | The ppq workshop is a 5day intense handson session devoted to developing the ability to identify what is at the root cause of a performance issue is and. |
| The ppq batches should involve increased sampling, testing, and scrutiny of the process performance compared to routine commercial batches to confirm consistent product quality within and between batches. | Once the desired number of ppq batches is prepared, it is prudent to evaluate the data and determine if there is any unexpected betweenbatch variability exhibited by the ppq batches. |
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