Quality by Design (QBD) and analytical methods

Quality by Design (QBD) and analytical methods have come into focus because of an inherent limitation in the guideline used for validation of analytical methods. The International Conference on Harmonization (ICH)’s Q2 guideline, Validation of Analytical Procedures: Text and Methodology serves as the guiding document for validation of analytical methods for pharmaceutical products. Since the most common approach to method validation is a one-time affair, there is need for guidance on how to implement continuous and consistent method performance.

Methods fail to perform as required or intended in the receiving laboratory because there is always the absence of an effective process for capturing and transferring the knowledge of those involved in the development. With too much emphasis on validation of the methods to meet regulatory requirements, the focus on what to do to make the process work during actual application seemed to be lost. It is to address this bottleneck that Quality by Design (QBD) and analytical methods took shape.

How do Quality by Design (QBD) and analytical methods make a difference?

QBD, in being “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management”; emphasizes the importance of having predefined objectives built into the development process. An analytical method, which is an analytical procedure that includes all steps in the procedure, constitutes an important step in the QBD lifecycle approach. Together, Quality by Design (QBD) and analytical methods become an important component of the three-stage process of method validation, which are:

  • Stage one, which relates to method design
  • Stage two, which relates to method qualification, and
  • Stage three, which is about continued method verification

 Reference:

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=791903

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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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