Continued Process Verification (CPV)
Continued Process Verification is the third phase of Process Validation in a production environment.
Ongoing assurance is gained during routine production that the process remains in a state of control.
The third stage as the validated state during commercial manufacture assures that the running process remains in a state of continuous control. Detecting unplanned departures from the process as designed is essential to accomplish this goal and adherence to CGMP requirements. The PANDA system by evaluating and displaying collected data and information therefor is a tool to detect undesired deviations. FDA requirements (§ 211.180(e) makes mandatory the collection and analysis of product and process data related to product quality) are entirely covered by the PANDA system through graphical, tabular and statistical analysis. Updating on a regular basis ensures a reliable and current oversight over or detailed insight into relevant data.
Process stability and process capability
FDA recommends wherever usable and feasible adequate process control, data collection and statistical procedures in measuring and evaluating process stability and process capability. Trending procedures and calculation are to be described. The PANDA system allows the definition of limitations so that overreaction or unintended process variability is detectable. Scrutiny of intra-batch as well as inter-batch variation is according to FDA requirements a useful tool for comprehensive Continued Process Verification (CPV). Continued monitoring and sampling of process parameters allow periodical assessment. FDA recommends meetings of the quality unit and production staff on a regular basis to what the PANDA system offers easily accessible and comprehensive documents. Improvements can be made and verified as well as maintenance of facility, utilities and equipment.
The process capability is a measurable property of a process to the specification, expressed as a process capability index (e.g., Cpk or Cpm) or as a process performance index (e.g., Ppk or Ppm). The output of this measurement is usually illustrated by a histogram and calculations that predict how many parts will be produced out of specification (OOS).
Two parts of process capability are:
- Measure the variability of the output of a process, and
- Compare that variability with a proposed specification or product tolerance
Continuous process verification is an enhancement of traditional process validation. For it includes continuous monitoring of the process beyond the qualification phase. Its objective is to prove that the manufacturing process is always mastered and controlled.
Continued 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 continued 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.