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Quality by design (QbD) promises an efficient manufacturing process with enhanced consistency product quality with high safety standards. It is the method by which the critical quality attributes of a biological product are identified, and appropriate manufacturing processes will be well defined. It can be achieved by performing a small scale, often multi-factorial experiments and utilizing the risk-based approach to quality. The Trainers and consultants in the R & D process Design and Development deal with the QbD process.

The basics

  • It is a systematic approach to pharmaceutical development and Medical software manufacturing.
  • Sufficient details of development and manufacturing information to be in regulatory submissions.
  • It does not equal Design Space (DS) and the design of experimental (DOEs)
  • The regulatory decisions will be based on scientific and QRM principles using the Software for medicine process development.
  • It does not need to be expensive, and it can also reduce the manufacturing and regulatory cost.
  • It is crucial for products included in generics and producing new pharmaceutical products.
  • Analytical testing is vital, and it plays a significant role in the development and implementation of QbD.


Elements in QbD

  • Quality Target Product Profile (QTPP) identifies the CQAs of the drug product.
  • Process design and understanding includes the identification of the entire critical material using the Robust Process Design software for pharma.
  • Product design and understanding comes with the identification of the Critical Material Attributes (CMAs)
  • A control strategy includes the specifications for Excipients, drug substances, and drug products, and it also controls each step in the manufacturing process.
  • Process design and understanding incorporates the identification of Critical Process Parameters (CPPs) and a thorough understanding of the scale-up principles linking CPPs and CMAs along with CQAs.
  • Process compatibility and continual improvement.

Importance of QbD in industries

  • Better understanding about dealing with
  • Less number of batch failures
  • Fewer variations to achieve consistency in manufacturing quality
  • Improved QbD approaches to pharmaceutical development offer the opportunity for a more flexible regulatory approach. For instances, manufacturing changes within the approved design space and are without regulatory approval or review.
  • Greater regulatory confidence of robust products
  • Reduction of any approval submissions
  • More drug availability and fewer recalls from the market.
  • The innovative process validation approach
  • Effective transfer over the technology
  • Real-time release through the PAT implementation
  • Good return on investment along with more cost savings
  • Continue improvement over the total product life cycle.


The process of QbD implementation

Quality by Design has received a lot of attention when it comes to the pharmaceutical community. Successful QbD implementation needs a complete understanding of the relationship between the critical quality attributes (CQAs) and the clinical properties of the product. Also, this includes the relationship between variability in raw materials.
  • A clear understanding of the chemistry and kinetics of the product.
  • Learning about the implementation of the physics and chemistry of the process, their translation and incorporation to the entire commercial process through R & D software.
  • Knowing about manipulating the chemistry and kinetics, so the commercial process is producing the lowest cost but highest quality product with no necessity over the rework.
  • Familiarize yourself with the equipment and the technologies that are available and being used not only within the pharmaceutical industry but in several other industries as well.  
  • Following all these with the right DOE software (Design of experiments) will help for the right QbD implementation. 

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