Overview of Analyses of Purified Pharmaceutical water through Proficiency-testing Schemes Results
Caterina Mazzoni, Anne Tirard, Abdelkader Boubetra
Published: October 01, 2021.
Abstract
Water is one of the major components used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent. Different grades of water quality are required depending on the different pharmaceutical uses. Chemical, physical and microbiological quality controls are essential to verify that the produced water meets the regulations in force. The methods that must be applied for quality control of water for pharmaceutical purpose are described in the international Pharmacopeia. However, laboratories have few means at their disposal to check obtained results and to prove their competence to drug regulatory agencies and customers associations. As Certified Reference Materials (CRM), Proficiency Testing Schemes (PTS) is an excellent tool to objectively check laboratories performances. Moreover, data collected in PTS represent a snapshot of the state of the art of tested analytical methods.
Keywords: Proficiency-testing schemes; Purified pharmaceutical water; Endotoxins, IN total organic carbon; Total viable aerobic germs; Quality control; Laboratory performance