QBD in Analytical Method Development

QBD in Analytical Method Development

QBD stands for Quality by Design. ICH Q8 (R), Step 2 defines QBD as “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. QBD in analytical method development is an important component, as we will see later.

QBD in analytical method development

QBD in analytical method development means that analytical methods are the most important means to QBD, since the results are always scientific. Analytical methods provide information about process understanding, process control and product quality. QBD in analytical method development is useful for the following reasons:

  • Gaining prior knowledge needed for initial risk assessment
  • Assessment of material quality
  • Performing in-process testing for timely process control decision, which helps adjust processes before failures start taking effect
  • Confirms product quality, since it is understood that product specification quality is not the sole determinant of quality
  • It provides data to help understand the process better and bring about continual improvement
  • It confirms success of process change through routine and non-routine analysis.

The flow

This is how QBD in analytical method development can be shown:

Target measurement=>Selection of technique=>Risk assessment=>Method development=>Control strategy=>Continual improvement

Reference:

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM301056.pdf

 

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