QbD || QUALITY BY DESIGN TOOLS || advantages of qbd

 

QUALITY BY DESIGN TOOLS

Quality by Design relies on the use of certain tools. These include prior knowledge, risk assessment, mechanistic models, design of experiments and data analysis, and process analytical technology. 

Prior Knowledge

According to ICH rules, prior knowledge includes information, knowledge, or skills that have been taken up via prior experience with processes identical to those in question and published data.

The tool can be used from the start of the development process and updated on a regular basis applying the data produced by the process.

In respect to QTPP and CQAS, prior information may be used as part of control techniques.

However, it's crucial to avoid placing an excessive amount of dependence on existing information because doing so might give up control over the production process.

Instead of creating data from scratch, it is preferable to make use of this tool to confirm existing information.

Risk Assessment

Prior to development studies, quality risk management must be carried out in accordance with ICH Q9 in order to identify high-risk factors that affect the quality of drug products. 

Critical variables are frequently chosen through risk evaluations, which must be carried out in accordance with scientific understanding. 

To build a control plan, these factors must then be further examined through experimentation.

Flowcharts, fault tree analysis, failure mode impacts analysis, hazard analysis and important control points, risk ranking and filtering, etc. are some of the frequently used risk assessment tools.

Process Analytical Technology (PAT)

PAT can be defined by the US Food and Drug Administration as "A system for designing, evaluating, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality."

PAT enables CMAs, CPPs, or CQAs to be monitored in real-time to show that the process is under control. 

It permits online measurements, which are particularly helpful for identifying problems, and also permits adjusting the operational parameters when deviations with an adverse effect on product quality occur.

A wide range of tools are included in PAT to collect physical, chemical, microbiological, analytical, and mathematical data and conduct risk assessments. 

PAT aids in the control of process parameters as well as product quality by establishing an interface between the process and the instrument as well as a feedback loop that can alter processing conditions.

Advantages of QbD:

Better risk management during the manufacturing process and enhanced process design result in higher assurance of product quality.

Cost reductions are a result of innovation, higher productivity, and decreased error possibility.

Enhances compliance with regulations and facilitates change management.

Faster releases are guaranteed by real-time testing during the process as opposed to the more conventional end-testing of completed goods.

Challenges to QbD:

  • Requires cultural change in the organizational approach to quality.
  • Expensive, requires management support.
  • Calls for collaboration between departments and there may be resource/workload Limitations.

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