Process Validation in the Twenty-First Century-Reference-Cited by-同舟云学术

Process Validation in the Twenty-First Century

Published:2016 Issue: Volume: Page:501-531
ISSN:1431-8776
Container-title:Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
language:
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Author:

Strickland Helen,Altan Stan

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-319-23558-5_19

Reference44 articles.

1. American Society for Quality (ASQ) (2008) ANSI/ASQ Z1.4-2008 (Milwaukee, WI)

2. ASTM E2709-10 Standard Practice for Demonstrating Capability to Comply with a Lot Acceptance Procedure

3. Bergum JS (1990) Constructing acceptance limits for multiple stage tests. Drug Dev Ind Pharm 16(14):2153–2166

4. Bryder M, Etling H, Fleming J, Hu Y, Levy P (2014) Topic 1—Stage 2 process validation: determining and justifying the number of process performance qualification batches, International Society for Pharmaceutical Engineering Discussion Paper. www.ispe.org/discussion-papers/stage-2-process-validation.pdf

5. EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP), Guideline on process validation for finished products - information and data to be provided in regulatory submissions 27 Feb 2014

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1. Planning of sequential binomial tests for various risk ratios;Quality and Reliability Engineering International;2017-11-24

2. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance;Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry;2017

3. Process Qualification: Stage 2 of the FDA Process Validation Guidance;Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry;2017