Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)

The approach of EMA to attributes is limited to critical attributes CQA and critical parameters CPP whereas FDA considers all attributes and calls them Quality Attributes (QA) and Process Parameters (PP).

 

 

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 quality attributes and process parameters via 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.