Abstract
The process qualification stage verifies that the commercial process developed is capable of reproducible commercial manufacturing. Stage 2 is required prior to product commercialization and establishes the process with scientific evidence that it is capable of consistently delivering quality drug products. Qualification activities for facility, equipment, and utilities (Stage 2A) are conducted prior to use in commercial Stage 2B activities.
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Pazhayattil, A.B., Sayeed-Desta, N., Fredro-Kumbaradzi, E., Collins, J. (2018). Stage 2A and Stage 2B: Process Qualification. In: Solid Oral Dose Process Validation. AAPS Introductions in the Pharmaceutical Sciences. Springer, Cham. https://doi.org/10.1007/978-3-030-02472-7_6
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DOI: https://doi.org/10.1007/978-3-030-02472-7_6
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