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QBD IMPLEMENTATION

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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