Scale-up and Post Approval Changes

EMA can provide information about problems that result from scaling-up production from laboratory through pilot scale to production. Properly gathering information about those processes during properly designed development and process optimization studies might avoid repetition of lengthy and costly tests.

For post approval change control CGMP (refer to European Commission guidance Type I and II) recommends procedures, that ensure that sufficient supporting data is generated and that maintain quality and control.

 

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.