Pharmaceutical Quality by Design Tools

Prior Knowledge

Knowledge may be defined as a familiarity with someone or something, which can include information, facts, descriptions, and/or skills acquired through experience or education.

The word “prior” in the term “prior knowledge” not only means “previous,” but also associates with ownership and confidentiality, not available to the public.

Prior knowledge can only be obtained through experience, not education. Knowledge gained through education or public literature may be termed public knowledge.

Prior knowledge in the QbD framework generally refers to proprietary information, understanding, or skill that applicants acquire through previous studies.

Risk Assessment

ICHQ9 quality risk management indicates that the evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient and the level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.

Mechanistic Model, Design of Experiments (DoE), and Data Analysis

Product and process understanding is a key element of QbD. To best achieve these objectives, in addition to mechanistic models, DoE is an excellent tool that allows pharmaceutical scientists to systematically manipulate factors according to a prespecified design.

DoE can help identify optimal conditions, CMAs, CPPs, and, ultimately, the design space.

Process Analytical Technology

The application of PAT may be part of the control strategy.

ICHQ8 (R2) identifies the use of PAT to ensure that the process remains within an established design space. PAT can provide continuous monitoring of CPPs, CMAs, or CQAs to make go/no go decisions and to demonstrate that the process is maintained in the design space.

These applications of PAT are more effective at detecting failures than end-product testing alone.

Application of PAT involves four key components as follows:

  • Multivariate data acquisition and analysis
  • Process analytical chemistry tools
  • Process monitoring and control
  • Continuous process optimization and knowledge management

The goals of implementing pharmaceutical QbD are to reduce product variability and defects, thereby enhancing product development and manufacturing efficiencies and postapproval change management.

It is achieved by designing a robust formulation and manufacturing process and establishing clinically relevant specifications.

The key elements of pharmaceutical QbD can include the QTPP, product design and understanding, process design and understanding, and scale up, control strategy, and continual improvement.

Prior knowledge, risk assessment, DoE, and PAT are tools to facilitate QbD implementation.

Finally, product and process capability is assessed and continually improved postapproval during product lifecycle management.

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Resource Person: BARBARA PIROLA

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