Quality Risk Management in Pharmaceuticals

Any process that can have any type of risk should go through the quality risk management. These risks may impact the quality of the pharmaceutical products. It is a requirement of good manufacturing practices. Quality risk management is an effective tool to maintain and improve the quality of the pharmaceutical products.

Risk assessment should be done in the following manner.

1. Initiation of Risk Management Process:

Risk management should be initiated with the listing of possible questions about the risks involved in the process or the system. Potential of the risk on human health and product quality should be identified. A time limit or deadline for the risk assessment should be specified.

2. Assessment of Risk:

Risk assessment includes the identification of hazards associated with risk. Following questions can help to identify and analyze the risk.

1. What may turn out badly?

2. What is the probability (likelihood) it will turn out badly?

3. What are the outcomes (seriousness)?

A) Identification of Risk: Risk should be identified by the available data as data from the history of the process or system, different opinions or the information derived from the end user. The question “What might go wrong?” helps to identify the risks involved in process or system and provides the base for the further assessment of the risk.

B) Analysis of Risk: After identification of risks involved in any process or system its analysis is done. The harms associated with the risk are listed and chances of their occurrence and criticality are determined.

C) Evaluation of Risk: The analyzed risk is compared against the risk criteria.

The outcome of the risk assessment may be either in the qualitative form as a number (1,2,3) or in the qualitative form (low, medium or high)

3. Control of Risk:

Risk control is the application of the methods or tricks to reduce the risk to the acceptable level. First of all, determine that the risk is above the acceptable level. Determine the way to control the risks. New risks should not be generated while controlling the risk.

During the implementation of risk reduction measures, it may affect the significance of other existing risks or generate new risks. Therefore, one should do risk assessment again to evaluate the changes in risks during the implementation of the risk reduction process.

4. Communication of Risk:

Communication of risk is the exchange of information regarding the risk between the decision management and others. The results of quality risk management should be documented and communicated. The information regarding the nature of risk, its severity, control and related information should be communicated. Dotted arrows in the figure indicate that communication in risk management should be done in every stage.

5. Review the Risk:

Risk management is a continuous process and a system should be implemented to review the risks at a fixed time interval. All events of the system should be monitored for the risks associated with it. The frequency of the review the risk management depends upon the severity of the risk. It should be mentioned clearly in risk management document.

6. Methodology:

Method of the risk management is given in the sample protocol.

Reference: ICH Q9 - Quality Risk Management.

Related: Risk Management Sample Protocol