Quality by Design

Improve your Manufacturing process by integrating Risk Control Strategy and

Process Analytical Strategy

With increasing focus on process optimization, Quality by Design (QbD) and Process Analytical Technology (PAT) is the next logical step for many pharmaceutical manufacturing companies​. Figuring out how to best support your process with technology can be challenging. HERAX will provide guidance in this phase, supporting the vendor selection process and recommending the best tool for the needs of your organization. 

Quality by Design is the key process methodology used to design manufacturing processes in the Pharmaceutical Industry by integrating Quality Risk Management, Formal Experimental Design and Process Analytical Technology.
Manufacturer benefits: 
  • Improved process knowledge 
  • Reduced QC testing 
  • Less batch failures 
  • Faster scale-up 
  • Reduced unexpected process deviations 
  • Improved regulatory documentation 
  • Continous manufacturing 
  • Reduced development and production costs 
Patient benefits: 
  • Earlier access to new products 
  • Improved accessibility 

Quality Risk Management, Process Analytical Technology and Design of Experiments

- Key concepts in QbD and how they are used in process development and process optimization

Quality Risk Management (QRM)

QRM is a method used to systematically assess, control, review and communicate process risks. 

A fundamental element in defining and evaluating Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs). 

It is a key concept in the development of the final Control Strategy 

Process Analytical Technology (PAT)

PAT is technology used to design, analyze, and control pharmaceutical manufacturing processes through  measurement of CPPs that affect CQAs. 

PAT is supporting the Quality Risk Management method in developing the final manufacturing process

Design of Experiments (DoE)

DoE is a method used to determine the relationship between factors affecting the process and the output of the process. 

A key method in systematically defining the product development process and in defining and adjusting the final manufacturing process

How can we help?


We provide you with the resources to support you and your organization in assessing the Manufacturing landscape in terms of both processes and technology. Outlining the As-Is process is an important step towards pinpointing potential optimization areas and implementing these in the To-Be process.  

At HERAX, our consultants have extensive knowledge in the manufacturing space. This understanding of the Quality by Design methodology provides a solid foundation for performing assessments of manufacturing processes. This is ideal for supporting a potential vendor selection and guiding the process for implementing a tool to support the process.  

Your partners in implementation 


Fast implementationand ensure successful adaptation of QbD and PAT by combining a proven Life Science specific project methodology with a “best-in-class" knowledge of the Product Development, Clinical Development, Manufacturing and Regulatory Affairs business areas.

When choosing HERAX, you will experienced in performing process optimization assessments as well as providing guidance on how to initiate, manage, and conclude a vendor selection process within the manufacturing space.

We will advise on industry best practices and important things to consider when moving to implement changes in the Manufacturing area. 

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