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Our QbD & PAT-driven processes

Maintaining quality has always been vital for the healthcare industry to protect the safety of patients and consumers. Quality by Design (QbD) brings quality to the fore from the very beginning of the product development and manufacturing process, improving efficiency as a result. After all, testing products at the end of the manufacturing process limits your options for correction. Quality cannot be tested into a product, it needs to be infused into it, by design.

 

Combined with Process Analytical Technology (PAT), QbD enables forward-looking companies to move away from traditional quality approaches and instead employ systematic, data-driven strategies to deliver quality outcomes.

 

QbD and PAT approaches are actively encouraged and expected by key regulatory authorities including the U.S. Food and Drug Administration (FDA)the European Medicines Agency (EMA)as well as through guidelines published by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Benefits of Quality by Design (QbD)

QbD offers a better understanding of the manufacturing process, making scale-up from laboratory to mass production significantly easier. While QbD/PAT introduces additional steps to the initial stages of the product development process, this investment (in terms of time, money and resources) protects against variability later on – minimizing risk, reducing waste and saving time in the long run.

 

QbD can also simplify regulatory compliance processes. By creating a formulation and process design space that ensures compliance, later adjustments within this design space (such as during scale-up or in the event of variation in raw material characteristics) do not need to be registered with regulatory bodies, preventing significant delays when bringing a product to market.

 

QbD approaches based on PAT also facilitate real-time release testing. This gives companies earlier information on product quality and means that any manufacturing problem can be dealt with faster, in a more informed manner.

 

QbD also puts the quality assurance framework necessary for continuous process verification (CPV) in place. CPV is an alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. Since CPV is done in real-time, negative trends during manufacturing can be rapidly counteracted with suitable measures. Thereby, product quality is maintained and batches do not need to be destroyed.

A QbD/PAT approach offers:

  • Assurance for patients and consumers that their medicines and supplements are of an enhanced level of quality, meaning they are consistently safe and effective
  • A more reliable supply, preventing out-of-stock situations, or the need to destroy batches due to poor quality
  • Better efficiency
  • Easier scalability
  • Simplified regulatory compliance
  • Easier real-time release testing

 

Our team at HERMES PHARMA has embraced QbD and PAT with enthusiasm, as the twin approaches lead to better quality products and frequently reduce manufacturing and regulatory costs, as well as time-to-market.