Integrated Process Modeling—A Process Validation Life Cycle Companion
نویسندگان
چکیده
منابع مشابه
Integrated Process Modeling—A Process Validation Life Cycle Companion
During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process deve...
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ژورنال
عنوان ژورنال: Bioengineering
سال: 2017
ISSN: 2306-5354
DOI: 10.3390/bioengineering4040086