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Nowadays, Quality by Design (QbD) is a systematic approach and fundamental requirements for pharmaceutical formulationsdevelopment. Where includes defining quality target product profile (QTPP), identifying critical material attributes (CMAs), critical process parameters (CPPs) and critical quality attributes (CQAs).
While QbD does increase the workload during the product development stage, it protects against variability later on, reducing risk and saving time.
The purpose of QbD is to assure the quality of a pharmaceutical product through scientific development and risk management tools. Where several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are applicable throughout the product lifecycle. Design space and control strategies for risk management are also QbD elements.
Objectives of QbD
– To achieve meaningful product quality specifications that are based on clinical performance.
– To increase process capability and reduce product variability and defects by enhancing product and process design, understanding, and control.
– To increase product development and manufacturing efficiencies.
– To enhance root cause analysis and post approval change management.
Elements of QbD
– Quality target product profile (QTPP) and Critical quality attributes (CQAs)
– Product design and Critical material attributes (CMAs)
– Process design and Critical process parameters (CPPs)
– Linking CMAs and CPPs to CQAs
– A control strategy (that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process.)
– Process capability and continual improvement
QbD tools and studies also include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT).
The basic objectives of DoE are screening, optimization, and robustness. It involves the execution of experimental design on the basis of suitable variables along with statistical evaluation of obtained responses and exploration of the design space using mathematical or graphical approach.
