GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance

Burdick, R. K., LeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L., Vukovinsky, K., & Zhang, L. (2017). GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance (pp. 173–191). https://doi.org/10.1007/978-3-319-50186-4_5