Quality by Design (QbD)– Introduction

Hey friends, in my next few blogs with this being the first, I shall be covering the aspects of quality by design and how it impacts the review and approval cycle. Every regulatory person should have thorough knowledge about quality by design concepts and requirements. Today’s blog introduces the concept and some key elements. I have provided links of important training workshops, case studies and guidelines for better understanding of this topic and will request you to patiently go through each of these links provided below.

Regulation and science go hand in hand and quality is an inseparable part of any drug development. Quality: a new paradigm was presented by ICH Quality Implementation working group way back in 2003. The emphasis was on - Developing a harmonised pharmaceutical quality system applicable across the lifecycle management of the product emphasizing on an integrated approach to quality risk management and science. 

So, what does this mean? It means that there was a need of a shift in mindset while managing quality. The conventional approach of quality management needed to be relooked and changed to a ‘science and risk-based’ approach. The emphasis precisely was on building quality into the product rather than ensuring the quality at the later stages by mere testing of the product. Modern science and technology were good enablers to achieve this and it was time to explore it to ensure the quality is maintained and monitored continuously throughout the product lifecycle and rather than just establishing it one time during the initial validation phases. The aim was to build a robust product, process, and quality system by utilising the acquired knowledge and having an integrated approach to development, manufacturing, quality involving both the Industry and the regulators.

To achieve the above objectives, it is paramount to have a systematic approach starting by:

·       Preparing a quality target product profile (QTPP) and critical quality attributes (CQA)

·       Having a development approach based on science and risk mitigation.

·       Preparing a design space, wherever possible, for flexibility of managing slight deviations.

·       Working on preparing a robust control strategy and

·       Working on principles of continuous improvement during lifecycle management of product

Each of the above is a vast topic in itself. I will be covering each of these in detail in my future blogs. Today I want you to become aware of the key guidelines. ICH Q8, Q9, Q10, Q11 have explained quality by design aspects. All these guidelines are important to understand as they work together in different stages of development and lifecycle management of a product. 

According to ICH, Good scientific development (Q8) in combination with Quality Risk Management [QRM (Q9)] and Pharmaceutical Quality System [PQS (Q10)] will improve drug quality and efficiency of pharmaceutical manufacturing. Comprehensive implementation of the three guidelines together is essential to achieve ICH Quality Vision.

Apart from the above, Development and Manufacture of Drug Substance (Q11) is about application of the concept of quality by design to drug substance and hence important to understand and implement.  Another guideline was issued by ICH to complement the ICH Q8 to Q11 guidelines, i.e. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Q12).

This concept is not new and slowly it has been adopted by many firms as it is highly recommended by regulators across the globe. There are regulatory benefits in adopting this approach leading to shorter review and faster approvals.

The ICH guidelines provide high-level concepts, so I would highly recommend all to go through the training materials from the workshop conducted by ICH, and EMEA which explains the concepts with case studies.

Resources :

1)              ICH Quality : Refer ICH Q8 to Q12            https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

2)              ICH training workshop : ICH Q8, Q9, Q10

            https://www.ich.org/products/guidelines/quality/training-programme-for-q8q9q10/presentations.html

3)              Case study : Refer the link provided below from the Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop                           https://www.ema.europa.eu/en/events/joint-european-medicines-agencyparenteral-drug-association-quality-design-workshop

Keep following my blogs for further knowledge on quality by design. Happy Reading!!