Quality by Design for Herbal Drugs: a Feedforward Control Strategy and an Approach to Define the Acceptable Ranges of Critical Quality Attributes

Abstract

The proposed methodology can help to promote the implementation of QbD for herbal drugs.

Development of an on-line Raman spectral analytical method for monitoring and endpoint determination of the Cornu Caprae Hircus hydrolysis process

“…Terminating the hydrolysis too early causes decreased hydrolysate yields, and terminating the endpoint too late causes increased energy costs. Thus, real‐time monitoring of amino acid concentrations is expected to increase understanding of the hydrolysis process, aid in decision‐making related to termination of the hydrolysis and supply a basis for implementing feedforward control of subsequent units to ensure product quality.…”

Optimization of a chromatographic process for the purification of saponins in Panax notoginseng extract using a design space approach

“…Recently, Quality by Design (QbD) and design space concept are gained increasing popularity in pharmaceutical manufacturing process, such as ethanol precipitation [17,18], powder blending [19], tablet manufacturing [20], pharmaceutical co-precipitation [21] and chromatographic process [22][23][24][25]. The application of http://dx.doi.org/10.1016/j.seppur.2015.09.035 1383-5866/Ó 2015 Elsevier B.V. All rights reserved.…”

Minimising variation in aspalathin content of aqueous green rooibos extract: optimising extraction and identifying critical material attributes

“…Some flexibility can be built into the extract production process to ensure that variability in raw material quality can be accommodated, although without moving the product out of specification. The concept and application of the principles of QbD have not only been advocated for pharmaceutical product development, but also recently for the production of botanical drug products . Design of Experiments (DoE) employing experimental designs such as a central composite design (CCD) or a Box–Behnken design and multivariate statistics for the optimisation and establishment of a control space comprise the inherent elements of QbD …”