The Problem of Worst-Case Variability in Cleaning Validation and Cross-Contamination Control: A Quality by Design Approach on Some Cephalosporin Residuals-Reference-Cited by-同舟云学术

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The Problem of Worst-Case Variability in Cleaning Validation and Cross-Contamination Control: A Quality by Design Approach on Some Cephalosporin Residuals

Published:2024-07 Issue:7 Volume:79 Page:961-972
ISSN:1061-9348
Container-title:Journal of Analytical Chemistry
language:en
Short-container-title:J Anal Chem

Author:

Mohamed A. Gad ,Zaazaa Hala E.,Amer Sawsan M.,Hassan Said A.

Publisher

Pleiades Publishing Ltd

Link

https://link.springer.com/content/pdf/10.1134/S1061934824700333.pdf

Reference42 articles.

1. FDA, Validation of Cleaning Processes (7/93), 2014.

2. APIC, Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants, 2016.

3. Mendenhall, D.W., Drug Dev. Ind. Pharm., 1989, vol. 15, no. 13, p. 2105.

4. Ghosh, A. and Dey, S., Int. J. Pharm. Qual. Assur., 2010, vol. 2, no. 02, p. 26.

5. Riaz, B. and Khatoon, H., J. Appl. Pharm. Sci., 2013, vol. 3, no. 4, p. 63.

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