Hybrid Approach

In some cases like in case of very few and very different batches a Continuous Process Verification might not seem appropriate. A hybrid form between traditional and continuous form can make sense. EMA recommends a decision for a defined strategy in defined stages of the process before starting validating and a clear documentation following the EMA requirements.

 

Process Validation with PANDA

The data integrating and consolidating analysis system PANDA (Process ANalysis DAtabase) is designed specifically for standard-compliant process validation in pharmaceutical production and supports the continuous manufacturing with its process and quality monitoring.

PANDA is an integrated database system providing information from different source systems like LIMS, MES and ERP. With PANDA raw material, drug substance and batch tree data, as well as development, process and machine data can be structured, linked and aggregated. The system enables you to prove the development of process parameters (data trending) over long periods and offers a wide range of analysis, monitoring and data treatment. This allows a high degree of assurance in the performance of the manufacturing process.

PANDA supports the Traditional Process Validation and the hybrid approach. But if you have implemented the validation with PANDA it will be easier and better to realize the process verification directly in a continuous manner (Continuous Process Verification).