Quality by Design

Quality by Design (QbD) is a systematic approach to the development of a drug with a focus on product and process understanding and process control, based on sound science and quality risk management.

Paul Murray Catalysis Consulting offers training and consultancy in all aspects of the implementation of Quality by Design including setting the QTPP, identifying CMAs and CPPs, performing risk assessments and managing control strategies, to enable to robust development of quality products.

Consultancy may include:

  • Supporting the risk assessments including:
    • identifying CQAs,
    • identifying, prioritising and quantifying process parameters and material attributes
    • understanding and interpreting the relationship between CPP’s, CMA’s and the CQA’s
  • Efficient use of appropriate experimentation to assess the effects of process parameters and material attributes:
    • DoE
    • Kinetics
    • Scale effects
    • Process robustness
  • Development and interpretation of control strategies

 DoE is an important component of QbD to ensure the critical process parameters (CPP) are defined and understood to ensure the process meets the required critical quality attributes (CQA).

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