Identification and Establishment of Operating Ranges of Critical Process Variables
Author:
Publisher
CRC Press
Link
http://www.crcnetbase.com/doi/pdf/10.1201/b13997-5
Reference7 articles.
1. KG Chapman. The PAR approach to process validation. Pharm Techno! December 1984, pp23-36.
2. AR Gardner, TM Smith, RG Gerber, DW Zabriskie. Worst-case approach to validation of operating ranges. In: B Kelley, A Ramelmeier, eds. Validation of Biopharmaceutical Manufacturing Processes. ACS Symp Ser No. 698. Washington DC: ACS Books, 1998,pp.69-79.
3. TM Smith, J Bodek, J Misczak, R Scott, E Wilson, DW Zabriskie. Establishment of operating ranges in a purification process for a monoclonal antibody. In: B Kelley, A Ramelmeier, eds. Validation of Biopharmaceutical Manufacturing Processes. ACS Symp Ser No. 698. Washington DC: ACS Books, 1998, pp.80-92.
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