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Quality risk management in pharmaceutical development.

Naseem Ahmad Charoo1, Areeg Anwer Ali

  • 1Blue Nile Pharmaceutical Factory, Khartoum, Sudan. naseem102@yahoo.com

Drug Development and Industrial Pharmacy
|July 5, 2012
PubMed
Summary
This summary is machine-generated.

Quality by Design (QbD) principles, including risk management and target product profiles (TPP), enhance pharmaceutical development. This science-based approach builds quality into products, ensuring patient safety and efficient resource use.

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Area of Science:

  • Pharmaceutical Science
  • Regulatory Science

Background:

  • ICH Q8, Q9, and Q10 guidelines promote a systemic, science-based approach to pharmaceutical formulation development.
  • Product development inherently involves uncertainty, necessitating robust risk management strategies.

Purpose of the Study:

  • To outline the application of Quality by Design (QbD) principles in pharmaceutical development.
  • To demonstrate how risk management and a target product profile (TPP) reduce uncertainty and build quality into products.

Main Methods:

  • Utilizing the target product profile (TPP) to define critical quality attributes (CQAs).
  • Conducting initial risk assessments to identify and mitigate risks to CQAs.
  • Designing products and processes to gain knowledge, manage risks, and meet TPP objectives.

Main Results:

  • A science-driven process enhances manufacturer transparency and reliability.
  • Focusing on patient risk and flexible development saves resources and reduces compliance risks.
  • Understanding risks to CQAs enables the construction of a meaningful design space.

Conclusions:

  • Within the design space, managing critical material attributes and process parameters ensures desired product characteristics.
  • Specifications based on product and process understanding facilitate real-time release, confirming quality rather than controlling the process.