Glossary

Quality by Design

Quality by design is a strategy mainly used in the pharmaceutical industry to maintain the quality of medicines using statistical, analytical and risk-management methodologies in the design, development and manufacturing of the different drug products. Several other industries use this strategy, but the pharmaceutical industry has embraced it the most in the last couple of years. The automotive industry has also been using the quality by design approach for several years. 

Quality by design also involves intentionally integrating quality at all stages of the manufacturing process, including research and design. This eliminates the chances of creating poor-quality products at the end of the production line. It also allows everyone involved in the production line to know the impact of their work on the quality of the products. 

The government and other relevant regulatory bodies are responsible for issuing Quality by Design (QbD) approvals to pharmaceutical manufacturers. Manufacturers without these approvals risk being fined or facing other penalties, including termination of their operating license. 

Elements of quality by design 

Before the government or any relevant regulatory body issues a QbD approval, the manufacturer has to integrate these five essential elements into their Quality by Design approach. 

1. Quality target product profile (QTPP) 

This includes the critical quality attributes of the product. The critical attributes of the product significantly affect the quality of the final product. Manufacturers need to identify and document these attributes before requesting QbD approval. Regulators will then have to assess these attributes to ensure they meet the minimum standards.

2. Critical material attributes (CMA)

The manufacturer needs to deeply understand the critical materials used to make their products. They also need to ensure the different materials are used in the right amounts and ensure the final product meets the consumers’ needs and maintains the same performance throughout its shelf life. 

3. Critical process parameters (CPPs)

The manufacturer needs to have a good understanding of the crucial process parameters because they have a significant impact on the final product. The CPPs must be regularly monitored and controlled at all production stages to ensure the process yields the desired QTPP. 

4. Control strategy

A control strategy includes detailed specifications for the drug substances, excipients, and final product and controls for each step of the production line. The control strategy should ensure that quality standards are observed at all the manufacturing stages. 

5. Continuous improvement 

The manufacturer needs to implement a mechanism to ensure ongoing improvements to all processes even after getting the QbD approval from regulators. 

Why it is important to integrate quality at all manufacturing stages

  • Ensures compliance with government regulations hence avoiding fines and other penalties for non-compliance. 
  • It leads to shorter lead times and getting to the market faster.
  • Reduces the number of customer complaints, which can boost the brand’s reputation in the market. 
  • It ensures safer, higher quality, optimized products.

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