GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance-Reference-Cited by-同舟云学术

GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance

Published:2017 Issue: Volume: Page:173-191
ISSN:1431-8776
Container-title:Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
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Author:

Burdick Richard K.,LeBlond David J.,Pfahler Lori B.,Quiroz Jorge,Sidor Leslie,Vukovinsky Kimberly,Zhang Lanju

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-319-50186-4_5

Reference18 articles.

1. Alsmeyer D, Pazhayattil A (2014) A case for stage 3 continued process verification. Pharmaceutical Manufacturing. http://www.pharmamanufacturing.com/articles/2014/stage3-continued-process-verification/?show=all . Accessed 7 June 2016

2. Altan S, Hare L, Strickland H (2016) Process capability and statistical process control. In: Zhang L (ed) Chapter 21 of nonclinical statistics for pharmaceutical and biotechnology industries. Springer, Heidelberg, pp 549–573

3. ASTM (2010) Manual on presentation of data and control chart analysis, 8th edn. Neubauer DV (ed), ASTM International, West Conshohocken

4. ASTM E2281 (2015) Standard practice for process and measurement capability indices. ASTM International, West Conshohocken

5. ASTM E2587 (2016) Standard practice for use of control charts in statistical process control. ASTM International, West Conshohocken

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