Pharmaceutical Quality by Design (QbD): Understanding its Principles

• By: Staff Editor
• Date: October 26, 2016
• Source: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf

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Pharmaceutical Quality by Design (QbD): Understanding its Principles

Quality is a prime factor of importance in this era of competition. More and more pharmaceutical companies today are embracing the principles of Quality by Design (QbD) for development and manufacturing. The principles of quality have been defined by three the ICH guidelines: Q8 on pharmaceutical development, Q9 on quality risk management and Q10 on pharmaceutical quality system.

QbD is a recent concept which has been included as an annex to ICH Q8 Guidance. QbD enables better process understanding, and a more scientific approach to development rather than mere testing of the final product.

ICH Q8 Pharmaceutical Development

The ICH guideline Q8 on pharmaceutical development is sub-divided into two parts: parent guidance and the annex. The principles of quality by design (QbD) are described in the annex of this guidance.

As defined in the guidance document, QbD approach to product development should include the following elements:

• Defining the quality target product profile (QTPP) as it relates to quality, safety and efficacy, considering e.g., the route of administration, dosage form, bioavailability, strength, and stability.
• Identifying potential critical quality attributes (CQAs) of the drug product, so that those product characteristics having an impact on product quality can be studied and controlled.
• Determining the critical quality attributes of the drug substance, excipients, etc., and selecting the type and amount of excipients to deliver drug product of the desired quality.
• Selecting an appropriate manufacturing process.
• Defining a control strategy.
• A systematic evaluation, understanding and refining of the formulation and manufacturing process, including identifying the material attributes and process parameters that can have an effect on product CQAs; and determining the functional relationships that link material attributes and process parameters to product CQAs.
• Using the enhanced product and process understanding in combination with quality risk management to establish an appropriate control strategy, which can, for example, include a proposal for a design space(s) and/or real-time release testing.

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Understanding and Implementing a Quality by Design (QbD) Program