Design Space Verification

The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working and alterations within the Design Space are detected, however do not have any impact on ongoing processes, because within specifications. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval. (ICH Q8)

Design space verification is normally appropriate on laboratory or pilot scale. On basis of already hereby collected data and experiences a target interval called normal operating range (NOR) is defined while scaling up the production. During the product lifecycle yet undiscovered or previously undefined and unidentified risks can be detected by observing the normal operating range (NOR). Parameters investigated might turn out to be not scale independent. If Traditional Process Validation was used before, design space verification is required and a verification protocol is to be added to the dossier. In case of Continuous Process Verfication design space verification can contribute to the validity of the design space throughout the product lifecycle. Design space verification than is considered as a part of continuous process verfication.

 

Design Space Verification supported with PANDA

PANDA is a flexible system to support the design space verification. CPP data of experimental processes can be captured in different systems like OSI PI or GECCO. Also CQA data can be already available via LIMS systems, via Excel or GECCO. In the process design phase, PANDA supports the responsible users in research and engineering with analysis reports which bring together the influencing process parameters and the resulting product properties. With PANDA system in this stage Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) can be defined and continuously monitored over the whole product lifecycle. Deviations from the design space are easily detected.