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  • CaliberLIMS

Positive Effects of Water Monitoring in Pharmaceutical Industries

Various business sectors use water for specific purposes. Pharma companies use water extensively during different stages of production. If manufacturing companies use water that is not of good quality, it affects the final product adversely. Therefore, the importance of water monitoring in the pharmaceutical industries is high.  The pharma companies have to meet the compliance requirement for water monitoring process as per 21 CFR Part 11 laid by US FDA and Annexure 11 laid by EU.

Uses of Water in the Pharma Sector

The manufacturing sector uses water as raw material, as an ingredient, and sometimes as a final product. Water is also used as a cleanser for rinsing equipment or the preparation of disinfectants and detergents. When water plays such an important role in the production and other processes, pharmaceutical industries must regularly check the quality of water. It should always be of superior quality. Therefore, water monitoring becomes an unavoidable task.

What is Water Monitoring and Why is it Important?

Water that is used in production or manufacturing units of the pharma companies passes through many stringent tests as per the guidelines laid by Current Good Manufacturing Practices (cGMP). The reason for such scrutiny is that the quality of water affects the final product as well. Therefore, water monitoring in pharmaceutical industries is essential. Water monitoring process is similar to sample management. Quality Analysts (QA) test water quality regularly using different machines and materials. This process helps to analyze water stability or issues at regular intervals of time. 

How does CaliberLIMS Water Monitoring Module Help Customers?

CaliberLIMS Water Monitoring Module helps in the automation of the water monitoring schedule process. It helps in fixing the number of intervals at which water monitoring should be done by analysts. The module automatically sets off alerts that help the concerned analysts to perform necessary tests to the water samples. It facilitates determining if the water is in usable condition as raw material, ingredient, or final product in the production process.

CaliberLIMS Water Monitoring Module helps in the

  • Registration of sampling locations
  • Schedules creation for auto sample login received
  • Submission of the analysis data
  • Evaluation of results as per pre-defined specifications, and
  • Creation of reports and trends for further scrutiny and analysis.

Thus, by doing so, CaliberLIMS Water Monitoring Module will help the customers in reducing operational costs. Pharmaceutical companies can eliminate manual steps and ensure regulatory compliance. It, in turn, leads to optimizing the process and controlling the quality of the water used. It also helps in viewing the real-time data. Therefore, automated process through the CaliberLIMS Water Monitoring Module facilitates the analysts to analyze the water quality, report issues on time, and make immediate and essential decisions.