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 activit...
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