Pp. 81-117 (37)
The quality of pharmaceutical products is permanently threatened by hazards
that are potential sources of harm. And hazards have an associated risk, defined as the
combination of the probability of occurrence and of the severity of that harm. Therefore,
it is necessary to keep these hazards under control by diminishing as much as possible
the related risks. This approach to quality assurance is known as risk management.
Different tools allow for the assessment of risk. Then, risk can be routinely monitored.
Yet, there are no magic tools. Risk assessment requires a good amount of knowledge on
the matter submitted to study. This does not exclude, however, that by skillfully using
the existing tools it is possible to appraise adequately the level of risk and decide on its
acceptance. A high residual risk is, in principle, inacceptable and requires the
implementation of measures for its reduction (changes in the process or system or in the
way it is monitored), whereas a low residual risk can be accepted. And this allows for
the introduction of continual improvement, understood as the progressive diminution of
the residual risk level. The whole process of risk management is explained step by step
and the most useful tools used in risk assessment are described providing practical
Cpk, Fishbone diagram, FMECA, FTA, HACCP, Hazard, HAZOP,
histogram, Pareto chart, PHA, process capability, risk, risk assessment, risk
communication, risk control, risk monitoring, risk review, RRF, specific tools,
Glez. Tablas 17, Barcelona, Spain.