Lyophilization Validation: Process Qualification and Continued Process Verification

Author:

Jameel Feroz,Alexeenko Alina,Bhambhani Akhilesh,Sacha Gregory,Zhu Tong,Tchessalov Serguei,Sharma Puneet,Moussa Ehab,Iyer Lavanya,Luthra Sumit,Srinivasan Jayasree,Tharp Ted,Azzarella Joseph,Kazarin Petr,Jalal Mehfouz

Publisher

Springer International Publishing

Reference26 articles.

1. Food US, Administration D. Others. Guidance for industry, process validation: general principles and practices. Rockville: Center for Biologics Evaluation and Research. US Department of Health and Human Services; 2011.

2. Jennings TA. Validation of the lyophilization process. In: Carlton FJ, Agalloco JP, editors. Validation of Aseptic Pharmaceutical Processes. New York: Marcel Dekker; 1986. p. 595–633.

3. Trappler EH. Validation of Lyophilization. In: Agalloco JP, Carleton FJ, editors. Validation of pharmaceutical processes. CRC Press; 2007.

4. The Parenteral Society, Technical Monograph No.7: Leak Testing of FreezeDryers. 1995.

5. U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry: Quality systems approach to pharmaceutical cGMP regulations. 2006.

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