Continuous Process Verification (CPV)

Continuous process verification can be an alternative to the traditional way of validating (Traditional Process Validation) or a supplement to it. It is considered by EMA as the most appropriate method for validating continuous processes (Process Validation).

The manufacturing process performance is continuously monitored and evaluated in accordance with ICH Q8, Pharmaceutical Quality Systems (PQS) and Current Good Manufacturing Practice (CGMP). Continuous process verification is a science and risk based real-time approach aiming to show, that specifically predefined parameters consistently lead to a production that meets all its Critical Quality Attributes (CQA) and other possible requirements. EMA recommends, as relevant, extensive in-line, on-line or at-line controls and monitoring of each batch. All relevant data is to be collected (verification of attributes, parameters and end points, assessment of CQA and CPP trends). Process Analytical Technology (PAT) and statistics but as well knowledge and understanding of the underlying process is needed. Continuous process verification is influenced by:

  • Prior knowledge from development and production of similar products
  • Information about processes obtained from development studies and experience
  • The complexity of product and/or manufacturing process
  • The level of automation and analytical technologies used

Legacy products referring to the product lifecycle, process robustness and manufacturing history

EMA offers a description of the continuous process verification strategy, which should be included into the developmental sector of a project supported by data from pilot scale batches. Recently generated data should be available.

 

 

Continuous Process Verification with PANDA

The PANDA system gives access at any moment and on every level of treatment to the data. Statistical evaluation and automated generation of reports is included. Newly generated data is imported on a regular basis in order to give current views as well as older data is stored. The applicant has a large variety of choices concerning data display and treatment.

Predefined parameters, all relevant data and findings are constantly controllable and visible, when ever needed. Accordance to Pharmaceutical Quality Systems (PQS) and Current Good Manufacturing Practice (CGMP) can thereby be assured. PANDA performs continuous process verification.

Integration and actualization of heterogeneous data from different sources (LIMS for CQA, MES or EBR for CPP) enables PANDA just by pressing a button to perform statistical evaluations of CQA and CPP considering all relevant initial or resulting parameters.

On the basis of this data automatically created reports record as well the stability of the production process as the quality of the generated product. As a matter of routine the generation of periodical quality reports is easy to perform. The reports include trendings, control charts, CPK calculation, histograms and many other analysis charts.

Continuous monitoring of the process parameters allows:

  • Minimizing risks within the process
  • Decreasing costs by reducing quality examinations

PANDA supports releasing processes of product batches on a periodical basis by releasing reports that can be configured.