Quality by Design (QbD)

In the last few years, FDA has implemented the concept of Quality by Design (QbD) into pre-market processes. Quality by Design is applied at the stage of (process) development. As FDA says in its guidance “Quality cannot be tested into products; i.e. quality should be built in by design”. Therefore Quality by Design is established in pharmaceutical production.

Instead of relying only on testing the finished products Quality by Design assesses at the development process.

With Quality by Design a design space which is defined as “The multidimensional combination and interaction of input variables (e.g.material attributes) and process parameters that have been demonstrated to provide assurance of quality” can be identified. As a result, quality issues can be efficiently analyzed and its root cause quickly identified. If all Process Parameters (CPP) are within the design space product quality is guaranteed. Manufactures save time and money in developing and producing drugs.

Quality by Design is an approach that defines product design, automates testing and optimizes troubleshooting.



Process Design supported with PANDA

PANDA is a flexible system to support the process design phase. 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) und Critical Quality Attributes (CQA) can be defined and continuously monitored over the whole product lifecycle. Deviations from the design space are easily detected.