Multivariate statistical process control in product quality review assessment

Multivariate statistical process control in product quality review assessment – A case study

Published:2017-11 Issue:6 Volume:75 Page:446-454
ISSN:0003-4509
Container-title:Annales Pharmaceutiques Françaises
language:en
Short-container-title:Annales Pharmaceutiques Françaises

Author:

Kharbach M.,Cherrah Y.,Vander Heyden Y.,Bouklouze A.

Publisher

Elsevier BV

Subject

Pharmaceutical Science,Pharmacology

Reference23 articles.

1. Product annual/quality review: US & EU comparative analysis and interpretations;Lee;Pharm Technol,2008

2. ICH Q7 good manufacturing practice guide for active pharmaceutical ingredients. Current step 4 version;ICH,2000

3. Pharmaceutical quality system Q10;Guideline;Curr Step,2008

4. The rules governing medicinal products in the European Union. EU guidelines for good manufacturing practice for medicinal products for human and veterinary use. Chapter 1: pharmaceutical quality system, Vol. 4;EudraLex,2013

5. Comparisons of multivariate CUSUM charts;Pignatiello;J Qual Technol,1990

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Root cause analysis of an out-of-control process using a logical analysis of data regression model and exponential weighted moving average;Journal of Intelligent Manufacturing;2023-04-05

2. Sequential fixed-fluidized bed foam granulation (SFFBFG) and drying: Multivariate model development for water content monitoring with near–infrared spectroscopy;Chemical Engineering Science;2022-11

3. A strategy for population pharmaceutical quality assessment based on quality by design;Journal of Pharmaceutical Analysis;2021-10

4. Dynamic and Statistical Operability of an Experimental Batch Process;Processes;2021-02-28

5. Developing machine-learning regression model with Logical Analysis of Data (LAD);Computers & Industrial Engineering;2021-01