Process Qualification

In this context Process Qualification is meant as one phase of Process Validation in production environment.

During the Process Qualification (PQ) stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

This phase corresponds closest to traditional process validation. It qualifies the equipment and the process. Each production process must be validated and so must all the equipment used. Process data has to be captured and monitored and Critical Process Parameters (CPP) in the production process have to be selected. Critical Quality Attributes (CQA) with regard of a satisfying product should be taken into consideration. On completion of process qualification, comprehensive process knowledge should have been established.

After successfully concluding the process qualification phase, the product is launched and commercial manufacturing of the product begins.

This stage has two important elements:

  • Design of the facility and qualification of the equipment/utilities.
    Here, the term qualification refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly.


 

Process Qualification with PANDA

The implementation of processes and the process qualification will be supported by the system PANDA. Latest in this phase the quality attributes (CQA) of substances and drug products as well as the process parameters (CPP) must be defined. Trend graphics (control charts) including the limit values have to be configured. With the statistical analysis and reports the process capability can be proven and documented.

The continuous accessibility of the CQA and CPP has to be established on the base of the imported LIMS data and machine process data. In the stage of process qualification, particularly in the PPQ, PANDA supports the pharmaceutical manufacturer via promptly available analytical reports about the accumulated quality and process data, which are the fundament for the qualification and the release of the production process.