Qualification Of Purified Water System For Non-Sterile Dosage Form
Abstract
Purified water is used to prepare pharmaceutical goods other than those that need to be made with sterile or pyrogenic water. The pharmaceutical business invests significant resources in the design and upkeep of water purification systems in order to control water quality, namely the microbiological purity, ionic impurities, and Total Organic Carbon (TOC). One needs a thorough comprehension of every modern technological component of a pharmaceutical PW system, as well as the justification for Food and Drug Administration (FDA) regulations for the manufacturing and storage of PW. Different water sources and the impurities they contain, the variations and similarities between the many types of water utilized in pharmaceutical facilities, and how the different types of water interact with one another are the elements that influence water system design.
Objective: To produce water with all desired qualities, water treatment systems must be validated. This provides evidence to create complete control over the process that evaluates efficacy and, eventually, the process results. The purpose of steering validation is to demonstrate that a process produces a product of consistent and definite quality with a high degree of confidence when carried out within predetermined boundaries.
Method: In the current endeavour, several techniques, water purification system machinery, equipment qualifications, performance testing phases, microbial and chemical analysis of water samples, documentation, and post validation monitoring are being considered. Validation is primarily carried out for new water plants in the pharmaceutical sector.
Result and Discussion: Water samples were taken after each stage of filtration, and the findings were within acceptable ranges.
Conclusion: The sample internal regulatory rules that apply to pharmaceutical manufacturing facilities must be followed when operating water purification equipment. Achieving validation successfully is verified by a number of testing stages. Typically, a three-phase testing approach is advised over a long period of time to demonstrate the system’s dependability and robustness for producing water with a high degree of assurance.
