Next Steps

Once the Equipment and Utility Qualificationprocess has been planned. R&D has determined the parameters, and scale up is in the process of being implemented, there are still items that need to be completed prior to the actual validation itself. The most important of these is performing a Process Qualification (PQ) during development of the process and/or during scale up. This PQ (this may in some cases be considered Engineering Runs) is not the Process Performance Qualification or PPQ that is the process validation. This PQ is to run the process in its entirety and to make sure that all parameters work together. During development, as with the qualification of the process equipment, each step of the process is tested individually. In the case of equipment qualification the Installation Qualification (IQ) and Operational Qualification (OQ) tests are all stand-alone pieces of equipment (see Chapter 5: Basic Equipment and Utility Qualification).

During the PQ testing adjustments can be made to the process, and recorded as was done during commissioning for the equipment. The equipment cannot be changed without a formal change control; however, at the stage of the PQ the system has not been validated for the process so changes are allowed (within reason, that being within the specifications previously established) as long as there is a good documentation trail. A well-run process PQ is important to the obtaining a complete and trouble free.

Thus, once the production has been developed, risk analyzed (more risks can be added during production if necessary), the APIs’ conditions established, the CPPs established, and the PQ and/or engineering runs performed, the PPQ can be prepared and the process validation program can continue.

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