Conclusion
Using the weighted determination coefficient method, CPPs can be determined with all the CQAs considered based on their importance. The determination of CPP number is more objective compared with the SPRC method.
Methods
The manufacturing process of Astragali Radix extract, which contained water reflux extraction, concentration, and ethanol precipitation, was used as an example. First, the multiple process CQAs were determined to be the yield of pigment, dry matter, sugars, and active ingredients. Second, the potential CPPs were determined by a knowledge organization method. Plackett-Burman designed experiments were then performed. A weighted determination coefficient ( R2w<math><msubsup><mi>R</mi> <mi>w</mi> <mn>2</mn></msubsup> </math> ) method was presented to identify CPPs. In this method, the importance of different CQAs was considered. Process parameters were removed one-by-one according to their importance index. The decrease in R2w<math><msubsup><mi>R</mi> <mi>w</mi> <mn>2</mn></msubsup> </math> was used to characterize the importance of the removed parameter. If the decrease of R2w<math><msubsup><mi>R</mi> <mi>w</mi> <mn>2</mn></msubsup> </math> was less than a preset threshold, the removed parameter was not a CPP.
Objective
Critical process parameters (CPPs) identification is an important step of the implementation of quality by design (QbD) concept. There are many CPP identification
Results
During the manufacturing process of Astragali Radix extract, the potential CPPs determined by the knowledge organization method were water consumption, reflux extraction time, extraction frequency, ethanol content, ethanol consumption, and concentration endpoint. Reflux extraction time, the first ethanol consumption, the second ethanol consumption, and the second ethanol precipitation refrigeration temperature were found to be CPPs using the weighted determination coefficient method with the threshold of 10%.