Quality risk management for manufacturing of pharmaceutical products - Concept and regulations

Risk management is the process of assessing corporate risk and developing various strategies to keep it under control (risk transfer, avoidance, impact reduction, acceptance of consequences, etc.). The concept first appeared in the United States in the 1960s, and evolved at the end of the 20th century, with different periods in its strategic approach: from simple claims management in the late 1980s, through to comprehensive insurance management, with the introduction of preventive measures and the development of industrial crisis management plans.

The late 1990s saw the emergence of risk management concepts, associated with the development of tools such as risk mapping. The aim of risk mapping is not only to identify, assess and quantify risks, but also to define measures, such as control plans, to reduce or eliminate them. Risk management promotes safety, and establishes crisis management plans by reinforcing the effectiveness of organizations and management systems, including new technologies.

As a genuine operational steering tool and strategic decision-making aid, risk management is a key issue for companies, involving all those involved (management, operational staff, etc.), in order to help protect their assets against the random and therefore financial risks to which they may be exposed. Risk management, through the implementation of an appropriate management system, is one of the most effective tools for achieving the company's performance and quality objectives. It has been used for many years in the telecommunications, aerospace, automotive and medical device industries.

In the pharmaceutical industry, these notions are now officially defined and integrated into regulatory texts, even if they are not yet necessarily enforceable. Nevertheless, risk concepts have been at the heart of pharmaceutical manufacturers' concerns for many years, and are reflected in GMP/BPF and pharmacopoeia monographs. It is the formalization of these approaches and the use of specific tools, accepted and validated by all, which are relatively recent in the pharmaceutical field and for which we must prepare ourselves.

In the healthcare sector, interest in the notion of risk emerged particularly after the contaminated blood tragedy in France in 1985. At hospital level, care assessment led to the principles of accreditation, then certification, which implement approaches based on risk management to ensure the safety of care.

The aim of this article is to present the main principles and regulatory bases of risk management in the pharmaceutical production of chemically synthesized drugs. As the industrial risks associated with biotherapies (design, production, marketing in particular) are quite specific and...