Process Qualification: Stage 2 of the FDA Process Validation Guidance-Reference-Cited by-同舟云学术

Process Qualification: Stage 2 of the FDA Process Validation Guidance

Published:2017 Issue: Volume: Page:155-172
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_4

Reference17 articles.

1. ASTM E2475 (2010) Standard guide for process understanding related to pharmaceutical manufacture and control. ASTM International, West Conshohocken

2. Breen C, Somayajula D A, Altekar M, Patel P, Lewis R (2016) Determining the number of process performance qualification batches using statistical tools—supplement to prior discussion paper

3. Bryder M, Etling H, Flemming J, Hu Y, Levy P (2012, updated 2014) Topic 1—stage 2 process validation: determining and justifying the number of process performance qualification batches (Version 2). ISPE discussion paper. (www.ispe.org/discussion-papers/stage-2-process-validation.pdf)

4. Chao S-B (2005) Risk-based approach for biological process validation: Integrating process validation with product development. J Validation Technol 12(1):54–68

5. Doymaz F, Ye F, Burdick R (2015) Product homogeneity assessment during validation of biopharmaceutical drug product manufacturing processes. In: Jameel F, Hershenson S, MA K, Martin-Moe S (eds) Appears in quality by design for biopharmaceutical drug product development. Springer Science & Business Media, LLC, New York, pp 649–659