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Food and Drug Administration (2019) Quality Considerations for Continuous Manufacturing—Guidance for Industry—Draft Guidance.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-considerations-continuous-manufacturing

has been cited by the following article:

• TITLE: Sinomenine Purification by Continuous Liquid-Liquid Extraction Process with Centrifugal Extractors

  AUTHORS: Zuren Peng, Wanying Wang, Xianjun Long, Ping Qiu, Qiaoqiao Liu, Yuanxiang Yang, Xuechun Yang, Meili Wang, Songmao Yin, Xingchu Gong

  KEYWORDS: Sinomenine, Continuous Manufacturing, Liquid-Liquid Extraction, Centrifugal Extractor

  JOURNAL NAME: Advances in Chemical Engineering and Science, Vol.10 No.3, June 17, 2020

  ABSTRACT: Continuous manufacturing is considered as one of the future trends of pharmaceutical engineering. In this work, continuous liquid-liquid extraction for sinomenine purification was realized with the usage of centrifugal extractors. Chloroform was used as the extractant because of the high distribution coefficient (>100). Higher extraction ratio can be obtained when using the centrifugal extractor of Model CWL50-N. The extraction ratio of the second-stage extraction was higher than that of the first-stage extraction. The extraction ratio of the second-stage countercurrent extraction was higher than that of second-stage cross-flow extraction. When chloroform phase was recycled for liquid-liquid extraction, the extraction ratio was also higher than 95%. This work can also be an example of continuous liquid-liquid extraction for the separation of other Chinese medicine components.