VALIDATION OF PHARMACEUTICAL GRADE PURIFIED WATER PURIFICATION SYSTEM

Abstract

Process validation is an important tool in the task of ensuring the quality of pharmaceutical products, thus being part of Quality Assurance. Validation is not only an aspect required by pharmaceutical legislation, but also a practice that is associated with several benefits, including the very reduction of production costs. Water is the most important raw material in the pharmaceutical industry, being indispensable in the broad processes carried out, from cleaning to the synthesis of drugs. Water purification aims to eliminate physical-chemical, biological and microbial impurities, which affect the correct functioning of operations, respecting the specifications of the health authorities. To carry out this process, methods such as filtration, deionization, ultrafiltration, reverse osmosis, distillation and ultraviolet radiation.