Risk Management in Pharmaceutical Industry

Risk management is a critical aspect of any industry, used as a baseline activity to identify and mitigate risk in their over processes. It enables an organization to identify system, process, or organizational structure hazards. Risk management also identifies gaps and shortcomings affecting any process and product.

In the pharmaceutical industry, risk management is performed regularly under standardized guidelines, and its results provide a great source of information for identifying risk. It is performed by the quality department, which makes arrangements for its resources and availability and tabulates the results for further discussion and final decision.

What is risk management?

Risk management is a continual process to identify, analyze, and treat risks facing critical processes in an organization. Its primary purpose is to prevent these risks' adverse effects before they become a disaster.

Risk management is a detailed process comprising multiple processes that contribute to a single purpose of eliminating risks. It can be performed for various departments and processes such as production, finance, maintenance, and supply chain.

Risk management is common is variety of industries around the world, especially in the manufacturing. The domain of the industry defines the way in which the activity is being performed. 

Risk management in the pharmaceutical industry

In the pharma industry, the main focus is product, and product quality is critical. With quality, pharma products are useful and can become dangerous for pharma organizations and their consumers.

For the pharma industry, risk management is defined as Quality Risk Management that intends to identify gaps in quality since quality is the shared responsibility of all the departments in a pharma organization, and all departments are responsible for the quality of the final product. In other words, QRM identifies and mitigates risks in all supporting departments in an organization.

Apart from benefit it offers, risk management is a regulatory requirement that requires a pharma manufacturer to deploy risk management in their critical departments and processes. 

Quality Risk Management according to ICH Q9

The quality risk management for the pharma industry is described in an official document known as ICH Q9. The ICH is the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and aims to provide harmonized quality guidelines among different regulatory bodies.

The ICH Q9 provides detailed guidelines about implementing quality management in the pharmaceutical industry, and these guidelines are divided into different sections for a successful QRM activity.

Let's discuss QRM according to ICH Q9 

Responsibilities

Quality risk management is performed by a team comprising personnel from different departments such as Quality, Engineering, Sales, and marketing. Each team must also contain or be supervised by someone with skill and expertise in QRM and must be able to understand its minor details. 

Before the activity

Before starting the risk management process, some steps are necessary to effectively complete the QRM because a detailed understanding of the problem, its consequences, and its scope are necessary for a successful QRM. 

Some steps in this regard are as follows.

● What is the problem or risk? Identifying the underlying risks or problems helps kickstart the activity effectively. It helps define the scope, resources required, and area to cover.

● Available information: Available information is the starting point and current scenario of the problem and the potential harm or hazards a risk is causing. Presenting available information is vital to start the activity and sets a guideline for the entire activity. 

● Leader of activity and resource allocation: Just like other activities, a skilled person must be nominated head of the team to ensure smooth working, effective and timely decision making, and prevent confusion. An experienced person with a deep understanding of processes and effective problem-solving techniques must be selected to lead the activity. 

Resource allocation is also critical for the success of risk management activity and must be allocated to facilitate the entire activity. Depending on the scope and nature of the activity, examples of some resources include documentation for the process, computer systems, previous records, engineering tools, and monitoring instruments.

● Timeline and deliverable: The timeframe for any process is essential, and the activity can only be fruitful if selected wisely and realistically. Additionally, the timeline must be established practically, considering the team's availability and resources. 

For the risk management activity, a timeline must be selected adequately, keeping in view the availability of the person and the area to be inspected because RM activity can disturb routine operations and subsequently will be difficult for production personnel to release the location of resources for the activity. Defining a timeline prevents delays in the activity and completes the activity promptly.

Deliverables means the outcome that is expected from the activity. The deliverables must be defined before starting RM. The scope definition can also help define deliverables, and activity must be tracked against both timelines and deliverables.

Risk assessment

The next and vital stage in QRM Risk Assessment is to assess risks associated with the process or department under consideration. It is the most critical part of the risk management process.

Typically, Risk Assessment is divided into Risk Identification, Risk Analysis, and Risk Evaluation.

Risk identification is identifying risk related to a particular process, area, or product by utilizing different options, such as historical trends and theoretical data about the assessed entity.

Risk analysis: in this stage, the identified risk is analyzed to drill down further details such as its classification and severity. 

Risk evaluation is the comparison of identified risk with the organizational goals or acceptance criteria, i.e., how the organization sees the risk to its success and reputation and whether the risk assessment activity shall proceed, depending on the consequences of the risk.

Risk Control

During risk control, the severity of risk is reduced to acceptable levels by introducing different techniques, precautions, and preventive & corrective measures. 

The level of risk control methods must be directly related to the significance of risk, i.e., where the risk is high, controlling measures should also be increased. Similarly, if the severity of risk is low, the risk control mechanism should also be of a low level.

Risk reduction:

Risk reduction focuses on efforts or steps to reduce the risk above acceptable levels. Some steps include mitigation techniques to reduce the severity and probability of harm, actions that detect the hazards, and quality risks.

Risk acceptance: 

This technique accepts the risk with its severity level because it is practically impossible to eliminate the risk, even with practical tools. The risk must be under or equal to the threshold level to prevent its consequences from harming the organization's overall structure and process. 

Risk communication

Since risk management is conducted by a dedicated team, as mentioned earlier, the outcome of the risk management activity must be shared with all stakeholders, such as higher management, relevant departments, and regulatory bodies. Its purpose is to share critical situations and any severe risks found out, and at the end of the activity, to share details and mark the closure of the risk management process. 

Communication can be inside or outside an organization.

Communication within an organization can be between different departments or higher management. It can also be outside, between organizations and other organizations, between regulatory bodies. 

The information shared can include the existence of a specific risk, nature of the risk, severity, control, or other aspects of risk critical to a pharma organization or the overall industry.

Risk review

Risk review is the process of reviewing risk from time to time to increase the effectiveness of QRM activity by continuously performing it rather than as a one-time activity. Risk review allows pharma process owners to monitor the risks by constantly reviewing them.

Risk review activity is necessary for many reasons. One of them is the adoption of new technology or a tool. Another reason can be due to events that continuously occur and can affect the current profile of assessed risks, making existing mitigation techniques ineffective.

Tools for Risk Management activity

Risk Management activity is performed by utilizing different tools. They must provide useful information about risk and its associated severity levels, and must be selected depending upon various parameters such as what is the process being assessed, area of operation and impact on the overall organization or industry.

The ICH Q9 provides details of tools and include the following

● Basic risk management facilitation methods

● Failure Mode Effects Analysis (FMEA);  

● Failure Mode, Effects and Criticality Analysis (FMECA);  

● Fault Tree Analysis (FTA);

● Hazard Analysis and Critical Control Points (HACCP);  

● Hazard Operability Analysis (HAZOP);  

● Preliminary Hazard Analysis (PHA);  

● Risk ranking and filtering; 

● Supporting statistical tools.

The selection of tools from above list depends on the type of risk and area of interest. For some scenarios there can be only tool sufficient for the activity, while for other instance, combination of these tools can serve the purpose.

What processes of pharma industry require Risk Management activity?

Quality risk management must be incorporated into existing processes and departments of a pharm organization to increase the effectiveness of risk management process.  Some processes and department that for which QRM must be performed, include, but not limited to 

Development

Pharma Facility

Equipment and utilities

Materials management

Production

Quality Laboratory (and stability testing)

Packaging and labeling.

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.