Traditional Process Validation

Traditionally process validation takes place after finishing the (pharmaceutical and process) development and prior to marketing efforts. Some process validations as part of the Process Validation lifecycle however may be conducted on the level of pilot scale batches mostly of about 10 % of the later production scale. For some cases patient´s risks or technical reasons have to be taken into consideration and alter this proportion. EMA set up references in order to distinguish between validations starting sooner or later in the production cycle. Some biotechnical methods of manufacturing as well defined by EMA oblige to a more rigid validation.

In specified cases (EMA provides information in this respect) non-standard methods of manufacturing can be applied

  • Experience with the same or essentially similar product or process (number of products authorized/marketed in the EU/EEA and number of batches (including information on scale) manufactured (names/marketing authorization numbers in the relevant EU/EEA member state is to be provided))
  • Amount of knowledge gained during the development of the product (number and scale of batches manufactured at each manufacturing site involved)
  • History of GMP compliance of manufacturing site for that type of process. The applicant indicates standard or non-standard manufacturing process and justifies his decision for new marketing authorization applications.


 

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. 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).