Quality risk management


Quality risk management is the “systematic process for the assessment, control, communication and review of risks to the quality of the active pharmaceutical ingredient (API) product across the product lifecycle”  (ICH Q9).

Risk management applies to all aspects of the API’s pharmaceutical quality, including the development, manufacturing, distribution and review of the processes (revision, inspection, submission) throughout the life cycle of the API including the selection and use of raw materials, solvents, packaging and labeling materials.


It is important to determine which variable has an impact and how much its variability is the source of damage or prejudice to the quality of an active pharmaceutical ingredient. In this sense, as with knowledge management knowledge management, quality risk management facilitates the achievement of pharmaceutical quality system objectives which are: to ensure the realization of the product, to establish and maintain a control phase and to facilitate continuous improvement.


Various tools have been implemented at Seratec to establish the criticality of a process or a procedure by means of an evaluation of each of the potential risks, for example by a risk probability index (Risk Priority Number or RPN) in the case of the FMECA tool. Criticality makes it possible to set priorities based on the calculation of the RPN that will be between a criticality of 0 (acceptable) and 100% (unacceptable).

The index 0 is total control where everything is controlled and no parameter is critical, while the index 100 would require that each parameter be considered critical because you have to control them properly. The scale’s continuum shows that it provides a level of control proportionate to the reduction of this risk, and therefore its acceptance..


Quality risk management is an integral part of an effective pharmaceutical quality system. It is a proactive approach for identifying, scientifically evaluating, and controlling potential quality risks..

The risk priority number combines the occurrence of a risk with reference to the past, the probability of detection that represents the present, and the severity of risk that refers to the future..

Thus in the development of the product and the establishment of prior knowledge, a risk assessment will define a design space of the API.

Developing the process and the understanding of its operation will be subject to risk assessment for the creation of its design space..

In the transfer of the process in production, risk control will establish a control strategy in the definition of auditing and monitoring systems.

Lastly, during the life of the product and commercial manufacturing, the history of the process will allow a review of the quality risk to identify and prioritize continuous improvement areas of the product and assess proposed changes.


Just as much as demonstrating understanding of the product and process, quality risk management also applies to meet the requirements of good manufacturing practice and to demonstrate the efficiency a quality system. In addition to processes, they are applied to all activities and processes that make up the Seratec pharmaceutical quality system..