Process Validation according to EMA
The current EMA guideline "EMA Guideline on process validation for finished products" is valid since February 17th 2014. It is brought in line with CGMP-protocols (Current Good Manufacturing Practice) and ICH documents (International Conference on Harmonization).
The EMA Guideline provides the realization of process validation with two different methods:
Also the mix of both methods is possible:
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.