Process Performance Qualification

Within the procedure of Process Validation in a production context Process Performance Qualification is an element of Process Qualification.

The second component of process Qualification is the Process Performance Qualification (PPQ) which is part of the process validation lifecycle that includes protocol, execution and final report. Additionally, today’s standards expect to verify that the equipment, facilities and utilities are also qualified at that stage. Furthermore, the final report of the PPQ stage also demands that recommendations of the testing required at the next stage are made. PPQ has to be successfully completed before starting commercial distribution of the (drug) product. Data from commercial-scale batches should support the decision to begin commercial distribution. Data from laboratory and pilot studies can issue additional assurance that the manufacturing process performs as expected.

FDA recommends that “the cumulative data from all relevant studies (e.g. designed experiments, laboratory, pilot and commercial batches) should be used to establish the manufacturing conditions in the PPQ”.

A written PPQ Protocol has to be created. It should discuss

  • The manufacturing conditions including operating parameters, processing limits, and component input
  • The data to be collected and when and how it will be evaluated
  • Tests to be performed and acceptance criteria for each significant processing stage
  • The sampling plan, including sampling points, number of samples, and the frequency of sampling. Sampling during this stage should be more extensive than typical during routine production.
  • Criteria and process performance indicators
  • Design of facilities and the qualification of utilities and equipment, personnel training and qualification, and verification of material sources
  • Status of the validation of analytical methods
  • Review and approval of the protocol

In this phase, PANDA (Process ANalysis DAtabase) is capable of monitoring essential process data via its interface to the operational data detection system (PDA or MES). It also supports the selection of Critical Process Parameters (CPP) and thus aids in setting up a control strategy.

 

 

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.