Abstract

REGULATORY CONSIDERATION ON GOOD MANUFACTURING PRACTICES COMPLIANCE OF WATER FOR PHARMACEUTICAL USE: A REVIEW

Sivangini Pandey*, Harvinder Popli, Shefali Singh and Bhanu Choudhary

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Abstract

The pharmaceutical sector is a water-intensive industry that requires various levels of water purity. To achieve pharmacopeial standards, pharmaceutical water treatment entails the removal of certain pollutants from municipal drinking water. Depending on the mode of administration of various medicinal drugs, different water quality categories are necessary. However, water used in the manufacturing of pharmaceutical goods must be either Purified Water (PW) or Water for Injections (WFI). Both have comparable chemical purity criteria, but differ in the amount of microbiological contamination they tolerate, which is evaluated by colony count and endotoxin level. Water for Pharmaceutical Use (WPU), unlike other commodities and process ingredients, is frequently pulled from a system on demand and is not subject to testing or batch or lot release prior to use. As a result, quality assurance is critical in order to match the on-demand requirement. Furthermore, certain microbiological tests may have incubation periods, causing the results to be delayed in water use. Control of the microbiological quality in Water for pharmaceutical use is of great importance. No less important than avoiding the proliferation in storage and distribution is the avoidance of biological contamination in the water treatment systems. The control over water quality, including microbiological and chemical quality, throughout the treatment and storage process, is therefore an important concern that is in keeping with Good Manufacturing Practices. The study provides an overview of the current water quality standards, as well as restrictions and safety implications. Also discusses GMP requirements and water usage inspections for pharmaceutical drugs.

Keywords: Water for pharmaceutical use, WHO GMP requirements, Quality of water, Inspections.