Application of near infrared spectroscopy and real time release testing combined with statistical process control charts for on-line quality control of industrial concentrating process of traditional Chinese medicine “Jinyinhua”

Author:

Jin Ye,Du Wenjun,Liu Xuesong,Wu Yongjiang

Publisher

Elsevier BV

Subject

Condensed Matter Physics,Atomic and Molecular Physics, and Optics,Electronic, Optical and Magnetic Materials

Reference36 articles.

1. FDA, Guidance for Industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, 2004. https://www.fda.gov/media/71012/download.

2. ICH, ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8 (R2), 2009. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf.

3. ICH, ICH Quality Implementation Working Group Points to Consider (R2): ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation, 2011. https://database.ich.org/sites/default/files/Q8_Q9_Q10_Q%26As_R4_Points_to_Consider_2.pdf.

4. EMA, Guideline on Real Time Release Testing (formerly Guideline on Parametric Release), 2012. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-real-time-release-testing-formerly-guideline-parametric-release-revision-1_en.pdf.

5. An approach combining real-time release testing with near-infrared spectroscopy to improve quality control efficiency of Rhizoma paridis, Spectrochim;Li;Acta Part A Mol. Biomol. Spectrosc.,2016

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