Principles of Quality-by-Design in Pharmaceutical Development | ICQ

What is Quality by Design?

The Quality-by-Design (QbD) concept is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management [ICH Q8 (R2)].

A key assertion of QbD is that quality is controlled not by simply testing the product, but rather by building quality into the manufacturing process by design. This is achieved by a control strategy that is based on both product and process understanding.

Practical Implementation of QbD Principles

Quality-by-Design implementation is facilitated in Stage 1 (Process Design) of the Process Validation Lifecycle.

Within this workflow, there are multiple risk assessments and deliverables that should be met to develop a robust process and analytical control strategy. They are:

These deliverables and risk assessments:

• form the basis of the design of the product;
• establish critical quality attributes (CQAs) and process performance indicators (PPIs);
• identify process parameters, material attributes, and raw materials with potential impact on CQAs and PPIs; and
• ultimately classify process parameters, material attributes, and raw materials as critical or non-critical.

All together, these items coalesce to create a comprehensive control strategy for the lifecycle of a product. A comprehensive control strategy derived from current product and process understanding assures process performance and consistent, quality production.