Quality by design

 QbD is systematic approach to development and begins with predefined objective and emphasises product, process understanding and process control, based on sound science and quality risk management. 

QbD enhance the assurance of product safety and effective drug supply to customer 

QbD also offer promise to significantly improves manufacturing quality performance 

QbD having below steps-

1. Define Target product profile (use, safety and efficacy of the product)

2. Define Target quality product profile - used by the formulator and process engineer as quantitative surrogate for the aspects of clinical safety during development.

Gather relevant prior knowledge about drug substance, critical raw materials and process operation in to knowledge space. Use risk assessment to prioritise for knowledge gaps for further investigation.

3. Design formulation and identify Critical quality attributes/ Critical material attributes of final product, which required to be controlled to meet Target product quality profile.

4. Develop a manufacturing process by which formulation can be produced with expected Critical material attributes.

Identify Critical process parameters and input (raw) material attributes that must be controlled to achieve these Critical material attributes of final product. Use risk assessment to prioritise process parameters and material attributes for experimental verification.

5. Establish a control strategy for entire process that may include input material controls, process controls and monitors, design space around individual and multiple unit operations and/ or final product tests.

Continually monitor and update the process to assure consistent quality.

QTPP (Quality Target product profile)- describes the design criteria for the product, and should therefore form the basis for development of the CQAs, CPPs and control strategy.