You said Quality by Design ?


In the 1990s, Joseph M. Juran worked out a new approach that aimed to plan and integrate quality in design to encourage innovation and reduce costs due to lack of quality. These concepts were applied for a long time in the automotive industry, for example. Planning applies to the product life cycle (link), is intended for a target that was designated at the same time as the customer by the of ISO 9000 series of standards, and innovation is required to accommodate the necessary changes in a process of continuous improvement.


It was only later, with the initiative of the FDA in 2003 - adopted by the international conference on harmonisation (ICH), that those same objectives for the pharmaceutical industry of the 21st century, with the patient as the target, were communicated. This initiative is at the origin of what was called the four legs of the chair of documents ICH Q8 to ICH Q11 as a solid base in the implementation of this new comprehensive approach for pharmaceuticals.

The objective is to integrate science with the life cycle of the product or procedure in the context of an integrated system of quality management (ICH Q10). The definition of Quality by Design (ICH Q8) is thus: “a systematic approach to development that begins with predefined objectives and emphasizes the need to understand the product and to control processes, based on sound science and quality risk management.”

The intent of the authorities is for the pharmaceutical industry to reach this desired state of an efficient sector, agile and flexible to the maximum, to reliably produce high quality products with minimal regulatory oversight.


The systematic integration of an extended approach requires that a robust quality system (ICH 10) supports these new scientific and innovative approaches. Seratec has long integrated quality as a proactive company system and part of the strategy of the management, initiating a reformatting of the design approach in line with the authorities’ incentives, and the training of our employees.

The design and the development integral to an active ingredient, and their documentation in a master file that complies with the “Quality by Design” approach however require the development of new processes that engage all the company’s driving forces. Once developed, these are subject to continuous questioning to make sure they are complete and mastered. Currently Seratec implements a partial quality by design approach, applicable to new processes, and wants the extend it to all of its processes. To do this, a number of tools and support processes have been formalized at Seratec, in line with the founding ICH recommendations.


ICH Q9 (2006) are guidelines on quality risk management principles and tools that can be applied to the development, manufacturing, distribution and documentation of processes throughout the lifecycle of pharmaceutical substances.

On these foundations, guidelines were published on pharmaceutical development (ICH Q8, 2009) which recommend presenting knowledge gained about a product and its manufacturing process by implementing scientific approaches and quality risk management. The manufacturer of pharmaceutical substances must therefore provide a comprehensive understanding of the product and manufacturing processes. Thus, the CTD file can be prepared for a first submission, and as product knowledge increases, changes (or variations) can be considered throughout the life of the product. The degree of regulatory flexibility concerning these variations becomes based on the level of relevance of the scientific knowledge provided.

Lastly, the ICH Q11 guideline (2012) applicable to active pharmaceutical ingredients concerns the harmonization of scientific and technical principles in order to describe and justify the development and manufacturing processes of APIs. The tools have been gradually introduced at Seratec to further integrate knowledge in the service of medicinal product quality.


Like Mr. Jourdain, Seratec has indeed developed a scientific and technical expertise in this context, based on science and risk-based decision making. The definition of a new systematic approach in design and manufacturing has expanded with the increase in​​activity and the experience acquired in the development and registration of our active ingredients.

An approach based on the pharmaceutical development of active ingredients is essential for the Seratec team. The physicochemical and biological properties of the active ingredient can indeed influence the performance of the drug (QTTP Quality Target Product Profile). For the active ingredient, these properties must be specially designed and identified for the medicinal product which will contain it. These properties can be related to one another and concern chemical properties and properties in a solid state (particle size, crystal shape and properties), properties that can play a key role in the pharmacokinetics (fate in the human body) of the medicinal product. Compatibility with the other components of the medicinal product or the inherent stability of the active ingredient are also design elements that can justify the performance of the medicinal product. Lastly the chemical purity of the active substance remains a minimum target of compliance with ICH and contents of impurities are often at the origin of a QbD approach. The establishment of the platform of development of active ingredients at Seratec therefore helps to assess the potential effect of these properties on product performance, the result of the design and development of the active ingredient is then expressed in the creation of its specifications that must also meet regulatory requirements.


In this context, the motivations of Seratec are rooted in science and the problems encountered, and our research and development must meet regulatory expectations by engaging all the expertise of our employees.

This is a short-term goal for Seratec. To do this we follow the strategy of excellence as a driving force of our business.