Risk Management in the Pharmaceutical Product Development Process

Abstract

The manufacture and use of a drug product, including its components, necessarily entail some degree of risk."-International Conference for Harmonization (ICH) Q9. This paper examines the role of risk management in pharmaceutical product development in the context of patient safety and drug efficacy. Its objective is to contribute to building a common understanding of this quality risk management among the various functional groups involved in developing, testing, manufacturing, and approving of drug products within pharmaceutical companies and regulatory agencies. Selected aspects of drug substance and drug product development are used to demonstrate principles of risk management in action and presented as case studies.

Risk Management in Product Design: Current State, Conceptual Model and Future Research

“…An explicit PD risk management process is presented in [18]. Several risk management processes for problem subsets exist, such as reliability & safety related risk management [19,20], focus on performance and quality risk in PD [21][22][23], risk management in software development [11], or risk management in highly regulated environments such as the pharmaceutical industry [12,13]. The main shortcoming of the process models is that they either focus on the management of specific risks within PD, and / or lack an integration with other functions and risk management processes in the company.…”

“…The remainder of the paper consists of a brief description of the research method, an overview of risk management process frameworks for PD, especially the ISO 31000 framework, a discussion of the PD risk management literature by process step, a summary of the findings, and the conclusion. Risk management processes [8,[10][11][12][13][14][15][16][17][18][19][20][21][22][23] RM process elements Communication and consultation [3,12,13,[17][18][19][20][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39] Establishing the context [14,18] Risk identification [14,18,[25][26][27][40][41][42]…”

Safety Assessment of Pharmaceutical Distribution in a Hospital Environment

“…For example, stocking patient-care units in hospitals with certain full-strength drugs, even though they are toxic unless diluted, has resulted in deadly mistakes. Robust preventative actions are therefore required to minimise the risks inherent to the prescribing, dispensing and administration of medicines (Marx et al, 2003;Burgmeier, 2002;Hulbert et al, 2008). The redesigning of subsystem processes is a goal that should be undertaken to improve the overall safety of hospitals.…”

“…The redesigning of subsystem processes is a goal that should be undertaken to improve the overall safety of hospitals. The manufacturing and the use of a pharmaceutical product necessarily entail some degrees of risk, as can be seen in the case studies presented in (Hulbert et al, 2008), and a wide variety of specific approaches can be adopted to appropriately assess, reduce and manage these risks. The use of risk assessment tools in hospital environments was formally introduced in the USA on 1 st July 2001, when the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) required each accredited hospital to conduct at least one proactive risk assessment annually.…”

“…In 2003, the Italian Healthcare Minister published a technical note on Health Care Risk Management and indicated FMEA analysis as a useful tool for risk identification and injury prevention (Ministero della Salute, 2004). Numerous authors have questioned the difference between reactive (Incident Reporting, Root Cause Analysis) and proactive (Failure Mode and Effect Analysis, Socio-Technical Probabilistic Risk Assessment) tools as the methods of choice in risk management (Burgmeier, 2002;Hulbert et al, 2008;Chiozza et al, 2009). Proactive methods are more readily accepted, because they exploit professional competences through a positive approach to problems by focusing on the examination of the entire process, while reactive tools focus on events rather than processes.…”