Risk Assessment for the Purified Water System in Pharmaceuticals : Pharmaguideline

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Risk Assessment for the Purified Water System in Pharmaceuticals

The risk assessment is a process that is used to identify and assess the potential hazards and risks associated with a project or activity.
The risk assessment is the process that helps to identify the risks associated with the process or system. Risk assessment is important for all pharmaceutical systems to know the potential risks for the product and the patients. In this article, we will discuss the risk assessment process for purified water system in pharmaceutical industry.

Why is Risk Assessment necessary?

Risk assessment is helpful in determining and mitigating the risks associated with any process or system. It helps to identify the potential risks and hazards and make appropriate decisions to minimize the effect of those risks. It also helps to identify the opportunities for improvement to ensure the successful completion of the project.

purified water system

Risk Assessment Framework

The risk assessment framework is to understand and manage the risks associated with any system or procedure. In pharmaceutical industry, risk assessment of purified water system has great importance to assess the potential risks of purified water purity.

Purified water systemis a critical component of the pharmaceutical manufacturing process to produce pharmaceutical products. It is important to maintain the quality of purified water all the time to ensure the quality of the manufactured products. There are many possibilities of purified water quality issues that must be assessed and managed to produce high-quality purified water.

One of the most common issues in purified water system is contamination by microorganisms. Microbes are found everywhere and they can contaminate the water system after entering from any point. Microbial contamination in purified water can contaminate the whole batch resulting in the failure of batch in microbial testing.

How is Risk Assessment done?

Risk assessment is the process to determine the potential problems that of affect the quality of purified water. These may occur during the generation or distribution of purified water system. So, in the pharmaceutical industry, the risk assessment of purified water system is used to determine the safety of water system and products manufactured using purified water.

The first step in the risk assessment of purified water system is to identify the risks that may occur. It includes spills and leaks of purified water, chemicals coming into contact of the water system or microbial contamination. In next step quantify the risk and figure out how likely the risk event may happen and what damage it can really cause.
Related: Purified Water System Validation

Finally, the risk assessment plan must address all identified risks. This includes the preparation of procedures to monitoring and cleaning of the water system and setting up the emergency response plans in case of any spill or leakage of purified water. It is to ensure that person working in purified water plant knows the handling of chemical exposures used in the water plant.

Risk Assessment for Purified Water System in Pharmaceuticals

Risk Assessment of purified water in the pharmaceutical industry can be done in the following steps.
Step 1: In risk assessment of purified water system, first of rate the severity (S) of the risk like Low=1, Medium=2 and High=3 according to the impact of it on product quality as follows.


Severity (S)

No Impact on Product Quality, Overall System Performance and/or Functionality, Operator Safety, exception or gap with respect to regulations or standards (GxP, EU, GAMP, ASTM, etc.)


Minor Impact on Product Quality, Overall System Performance and/or Functionality and Operator Safety.


Major Impact on Product Quality, Overall System Performance and/or Functionality, Operator Safety and Exception or gap with respect to regulations or standards (GxP, EU, GAMP, ASTM, etc.)


Step 2: Now rate the frequency of occurrence (O) like rare=1 occasionally=2 and frequently=3 as follows.


Occurrence (O)

Occurrence is extremely rare or unlikely


Occurrence is occasionally


Occurrence is almost every time the system is used


Step 3: Rate the likelihood of detection (D) as Low=3, Medium=2, High=1 as follows.



100% detection or inspection technique is in place specifically for the failure like an alarm, interlock, and error message or system shutdown.


Detected by indirect means or by observation like indirect indication or visual inspection.


No specific detection method


Step 4: The risk priority number (RPN) is determined by multiplying above three numbers.
Severity of failure (S) X frequency of Occurrence (O) X Detection (D)
Then final rating of the risk is given according to the following table.



RPN £ 3

Low (L)

9 ≥ RPN > 3

Medium (M)

RPN > 12

High (H)

Step 5: The risks with high RPN are addressed first and so on and enter the data in the table as shown in this sample document. Write the proposed risk control measure for each identified risk and reclassify again after risk mitigation as per the above classification procedure. Write the revised classification number in the table as shown in the sample document.

It is of great importance to know the risks associated with purified water generation and distribution system because purified water is used in pharmaceutical manufacturing at various stages like granulation, coating and washing of the manufacturing utensils and equipment. By using above mentioned steps you can do risk assessment of purified water generation and distribution system. If you face any problem in risk assessment of any system or process in your organization, contact us and we will help you to identify and mitigate the risks associated with your system or process to make it smooth and risk free.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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