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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QBD Analytical Method

QBD Analytical Method

ICH Q8 (R2) describes the nature of Quality by Design (QBD). QBD is a systematic approach to pharmaceutical manufacturing and development. Based on exact science with incontrovertible evidence, QBD aims at bringing about product and process understanding and process control. QBD seeks to bring all these about by beginning with predefined objectives.

Structure

The flow of processes in a QBD approach would typically be thus:

  1. selecting the product profile
  2. defining the critical quality attributes (CQA)
  3. performing risk assessment by linking raw material attributes and process parameters to CQAs
  4. cultivating a space for design
  5. arriving at a control strategy
  6. accomplishing product lifecycle by making continual development an integral part of it.

Analytical methods used in QBD

Both analytical and advanced analytical methods are used in QBD to achieve the end result of product and process development.

Analytical methods:In using analytical methods, QBD makes use of measurement of Critical Quality Attributes of everything relating to the product –the raw materials, intermediaries and the final product. Secondly, it supports risk assessment based on these qualities.

Advanced analytical methods: In order to achieve and enhance greater manufacturing control, a QBD uses analytical methods, which form the basis of Process Analytical Technology (PAT) and Real Time Release Testing (RTRT). This is done for process monitoring and for achieving continual improvement.

What purpose do these analytical methods achieve?

Precise analytical methods help achieve the following:

  • they help aggregate the selected product profile
  • they enable exact measurement of product CQAs and the intermediaries used in the process
  • they help identify and fix measurements and controls used in the process
  • they provide inputs with which to track and trend processes, leading to continual improvement in the process and the product.

 

Reference:

http://www.isranalytica.org.il/Isranalytica2012/2012%20CMoore%20Isranalytica%20Analytical%20QBD%20%28Tel%20Aviv%29.pdf