| Popis: |
In a quality by design (QbD) program, once a process has been characterized and a design space is established, process control of critical quality attributes (CQAs) needs to be assessed and an integrated control strategy , including both process controls and analytical testing (including release limits), needs to be confirmed. Three essential components of the control of a biopharmaceutical product are discussed in this chapter: (1) the process of identifying CQAs; (2) elements of the process, formulation and analytical control of commercial product; (3) the associated concept of a comparability study which may be used to help manage changes to the manufacturing and analytical processes, and thereby facilitate management of the quality of the product. |
