QUALITY AND REGULATORY ACTIVITIES
Quality and Regulatory Activities
TRANSFORMATION OF QUALITY AND REGULATORY ACTIVITIES: THE HUMAN AS AN ESSENTIAL ENABLER
Transforming an organization will depend on the context or environment, the expectations of health authorities and increasingly numerous and interactive third parties. Development of new technologies and, above all, collective intelligence are key allies in supporting the transformation.
A PUBLIC HEALTH CONTEXT CALLING FOR A TRANSFORMATION OF ORGANIZATIONS
The evolving expectations of health authorities in the development, production and distribution of health products is commensurate with recent technology revolutions. The internal management of Life Science must become holistic to integrate each entity to serve the ambition. Quality and Regulatory Affairs (Q&RA) must contribute to this approach by ensuring trust between various stakeholders, including regulatory authorities. Trust is fundamentally based on demonstrating the mastering of product quality and systems, but also on the relationship between the manufacturer and the authorities. The technical and scientific exchanges, the Registration Dossier, or the communication along the product life cycle are all opportunities to create trust.
Expectations have been set since the publication of the ICH: product quality must be characterized by scientific and technical evaluations that lead to the definition of product Critical Quality Attributes (CQAs). Delivering products with CQAs within a fixed range of variability, permanently, must be ensured by the control of the manufacturing process via the critical process parameters (CPP). The product and process quality itself guaranteed by the implementation of a quality system allowing the control and sustainment over time.
All these data are described in the registration files.
The challenge is to establish the right level of constraints and requirements to ensure the safety and effectiveness of the product from the first submission, while maintaining some level of agility that allows for subsequent evolutions.
As a result, manufacturers must adapt their organizations, and in particular break down siloed organizations, to meet the new challenge of knowledge management (formal and unformal) throughout the Life Cycle of the product.
During regulatory inspections, health authorities verify that companies are producing a quality product, in a sustainable manner, and without recuring remarks or corrective measures. Compliance and the application of good practices are no longer the only elements evaluated. The implementation of a quality culture and the leadership for its sustainment, are becoming essential.
AN EVOLUTION TO BE
DRIVEN BY THE TEAM COLLECTIVE STRENGTH
Technological innovations offer new challenges and opportunities: product modeling, therapeutic effects and side effects anticipated by artificial intelligence, modeling by Design of Experiment (DoE), Quality by Design (QbD) strategy, digitalization, abstraction of industrial operations. These are all new areas for better control of product and process quality. Nevertheless, the human factor remains central to decisions in research, development, manufacturing and distribution of therapeutic or prophylactic products. The growing complexity, brought by the necessary systemic understanding of decisions and their impacts, requires an integrated management of skills, staff education and training, and the setting in motion of a collective intelligence within the company. These measures are becoming essential for product/process quality and regulatory affairs. They are part of the audit and inspection scope and strongly contribute to the trust of stakeholders.
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It is through cross functional collaboration and expertise, putting the human at the center, shared experiences, coherence of operational practices with the construction of regulatory files, and inspections, that the manufacturer can gain trust with efficiency. QbD and the application of the ICH Q12 make it possible to structure the regulatory file and facilitate its maintenance. But it is the cross functional competences, the quality culture of the company, the operating modes between functions that make the difference.
If the contributions generated by technological innovations are precious, the human remains at the center of the decision process.
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A MULTI-CONNECTED
ENVIRONMENT
In the Life Science world, the areas of quality and regulatory affairs are increasingly interconnected and involve many stakeholders.
Firstly, the regulatory agencies and supranational organizations (ICH, EMA, PIC/S, etc.) impose different mechanisms for preparing or developing dossiers (how to write, how to interact, scientific advices). The management of regulatory inspections must also be adapted to the expectations, the culture and the specific practices of each agency in order to meet the challenges and gain trust.
The relationship with operational third parties (CMO, CDMO, CRO), particularly in new therapies (ATMP) and biotechnologies, involves knowledge sharing and quality requirements, as well as mastering supply chains that are often complex and must include risk management.
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With the multiplication of stakeholders, the systemic approach to quality and regulatory activities becomes crucial.
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Indirect external stakeholders such as associations, media, patients and prescribers are also involved in the Q&RA dimensions. Beyond the requirements of vigilance, including the monitoring of social networks, the perceived and communicated quality (media, networks) is a reality that cannot be ignored.
EVOLVING REGULATORY EXPECTATIONS
The regulatory requirements are constantly evolving (CFR 21, Eudralex Part IV, Annex 1). This leads to opportunities for interpretation where each agency and each inspector may have a specific interpretation. International standards (ISO 9000, 13485, ICH standards - Q8 Q9 Q10 Q12) are guides for defining approaches and implementation strategies, then they should be interpretated to establish the company's Q&RA policy. The associations (PDA, A3P, BioPhorum, etc.) of manufacturers and suppliers in the pharmaceutical and biotechnology industry are other sources to identify guidelines and find aligned approaches.
These different rules, standards, proposals or guidelines (whether enforceable or not) have degrees of possible interpretation and it is up to the manufacturer to equip itself with systems to explain and justify its understanding and practices (scientific and technical rationales).
Finaly Q&RA structures, in collaboration with scientific and technical functions, must define and conduct a policy adapted to the organizational, the human and cultural realities of the company. Here again, collective intelligence will be at the heart of the efficiency and agility of the system.
EXPERTISE PER BUSINESS DOMAINS
EXPERTS
Christophe Meunier
Antoine Akar
Jacques Zimmowitch