It’s 4TE story time! Today, we’ll talk about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework. 

As usual, our characters are confidential, but we are sure that we’ll be able to give you all the key insights about it. Are you ready to go on an adventure? Let’s go!  

A Company who needed some help!

Let’s start by meeting our main character: a pharmaceutical company whose objective was to develop an oral solid dosage of a generic active pharmaceutical ingredient and accelerating its time-to-market, assuring its efficacy, quality, and safety to the patients. 

At first sight, we already know that having a Quality by Design (QbD) framework is fundamental to achieve these goals.  

According to the ICH Q8 (R2), Quality by Design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management

In other words, we can say that QbD is a method that assures that a process will consistently deliver product quality and patient safety based on an in-depth process understanding. But the question is, how can it be applied to a real situation? 

That’s our role in this story: help this company putting the QbD concepts into action! 

How to define a Qbd Framework?

We’ve got the expertise when it comes to defining QbD frameworks! 

First, we started by establishing a Quality Target Product Profile (QTTP). Then, we went to define Critical Quality Attributes (CQA) by assessing the risks for the patient in terms of impact and uncertainty: 

  • High impact, high uncertainty: CQA 
  • High impact, low uncertainty: CQA 
  • Low impact, high uncertainty: CQA 
  • Low impact, low uncertainty: non-CQA 

Once all these tasks were completed, it was time to plan and execute the Design of Experiments (DoE) that led us to a definition of a Design Space (DS). 

We can say that a Design Space is the multidimensional combination and interaction of input variables and process parameters that demonstrates assurance of quality. Or, in other words, it’s the relationship between the process inputs and the Critical Quality Attributes.  

This was a crucial step. It allowed us to define in what ranges we could safely operate without impacting product quality. 

At the same time, we listed all preventive and detective controls, sampling frequencies and in-process controls. Finally, we’ve supported defining a strategy to manage post-approval changes. 

Have we accomplished our mission?

The answer is yes, it was an absolute success! 

With our intervention, the company was able to put into practice the QbD concepts. Besides, it was able to create a knowledge base for the product and easily evaluate the impact of process changes. This, obviously, supported science and risk-based decision making. 

Following a QbD methodology, the company could achieve its goal: develop a flexible yet robust manufacturing process. And, more than that, assure the quality, safety, and efficacy of the products for patients. 

We can help you implementing a QbD framework! 

Our team gives you all the support to implement a Quality by Design framework in your processes. 

Due to our full understanding on QbD framework implementation and our proprietary technology, we can help you with design space, process controls and in many other relevant topics. 

Your company can be our next story, take a look at our QbD services and feel free to contact us! 

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