Page 242 - Applied Pharmacognosy

Types of Chemical markers

Quality by Design (QbD) of
Biopharmaceuticals

Testing final product alone cannot be relied
upon to ensure product quality.
Quality control strategy should be built into the
manufacturing process to ensure product
quality (QbD).
The process is continuously evaluated to allow for
consistent quality throughout product life cycle
Biopharmaceuticals manufacturer designs its own
QC strategy based on the predetermined