What is qbd

QTPP is the quality characteristics of a drug product that is pre-defined and pre-designed during the development phases of the product. Some of these characteristics include:. CQA is the physical, chemical, biological, or microbiological property or characteristic of an output material including finished drug products that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

The quality attributes of a drug product may include:. Critical Process Parameters CPPs are identified by determining the extent to which any process variation can affect the quality of the product. Actual experimental data, product experience, or literature guidance can be used to define the extremes of the parameter sets to be refined.

Your email address will not be published. Notify me of new posts by email. Skip to content QbD Definitions Quality-by-Design QbD : 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 Quality Target Product Profile QTPP : a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.

Quality Attribute QA : a physical, chemical, or microbiological property or characteristic that directly or indirectly relates to pre-defined product quality safety, identity, strength, purity, and marketability of the product. Critical Quality Attribute CQA : a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure product quality Process Parameter PP : a process variable e.

Real-time analysis by FTIR or Raman spectroscopy provides critical reaction kinetic and trending information:. Automated chemical reactors and automated sampling offer precise control and monitoring of reaction variables:.

Real-time, in-situ particle size analyzers provide important insight into the following crystallization processes:.

Automated Reactors and In Situ Analysis. Transport and Logistics. Expertise Library. Literature: White Papers, Guides, Brochures. Technical Documentation. On Demand Webinars. Live Events. Live Webinars. Management Investor Relations. Service Finder Videos. Select Country. What is Quality by Design QbD? The steps in the process include: Definition of a product quality profile that represents in-vitro how the product will perform in-vivo.

This profile is a quantitative representation of the clinical safety and efficacy targets for product developers. Summarizing and centralizing what is known about the Active Pharmaceutical Ingredient API , excipients and process, and identifying knowledge gaps in order to prioritize study based on risk evaluation Design of the composition of the product and careful definition of the quality characteristics that need to be controlled in order to achieve the product quality profile Development of a flexible process for the product that has the defined quality characteristics Determination of key process specifications and starting material characteristics to be managed in order to achieve the desired end product characteristics.

To have a flexible process requires that the acceptable performance envelope of the process is well defined and the boundaries of acceptability are well understood. A methodology, such as Design of Experiments DoE , may be used to aid in process performance. Establishment of an overall control strategy for all aspects of the manufacturing process.

Risk assessment for the various steps should be considered in the control process. PAT methodology may be employed as part of the overall control strategy. Constant auditing of the manufacturing process and revision, as necessary, to maintain final product quality. However, this approach has the following challenges: Product quality and performance supported by end product testing leads to: Limited understanding of the process or key process parameters based on risk assessment Limited science-based understanding of process, managing of key variables and their affect on end-product quality.

Limited understanding of process design space and relationship to product quality In general, there is less time devoted to understanding why processes fail and more emphasis on testing and reworking out-of-spec product as necessary. Quality assured by testing and inspection also results in: Data intensive submission, disjointed information without consideration of the entire process Specifications based on batch history A validated and approved process discourages changes Focus on reproducibility, often avoiding or ignoring variations.

Quality built into product and process by design, based on scientific understanding Knowledge-rich submission — showing product knowledge and process understanding Specifications based on product performance requirements Flexible process within design space — allowing continuous improvement Focus on robustness — understanding and controlling variations.

Potential Challenges Associated with Quality by Design All stakeholders must be in agreement Corporate inertia Initial cost of new equipment and training Developing a Quality by Design-oriented information system to capture necessary documentation Supply chain issues Regulatory standards by which to judge Critical Quality Attributes CQAs , analytical methods, etc.

Global acceptance or lack of Lack of understanding of actual cost savings and positive business model. Technology for Quality by Design Real-Time Understanding of the Impact of Process Parameters Design, analyze and control manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials.

ReactIR, ReactRaman, EasySampler, ParticleTrack, EasyViewer, pH, calorimetry Confirm that the process is operating within design space via process monitoring and trending Use knowledge derived from process performance monitoring to continually improve process within design space Enable real-time release of intermediates or an end product.

Request More Information. In-situ Spectroscopic Analysis Real-time analysis by FTIR or Raman spectroscopy provides critical reaction kinetic and trending information: Use in conjunction with Design of Experiments DoE for defining critical process parameters CPPs and design space Develop a control strategy for process and incorporate into production Ensure that the process is performing within operating space Support process validation efforts in process design, qualification and verification stages.