Tony Gould.ppt

January 2006 World Health Organization Pharmaceutical Water Systems Objective General information on water systems Design and engineering aspects of water systems Inspection of water systems Background to water requirements and use Water is the most widely used substance / raw material Used in production, processing, formulation, cleaning, quality control Different grades of water quality available Background to water requirements and use Control quality of water Production Storage and distribution Contaminants, microbial and chemical quality Microbial contamination risk and concern Water is used on demand not subjected to testing and batch or lot release before use, therefore has to meet specification on demand when used Micro test results require incubation periods Water system requirements Design, installation, commissioning, qualification / validation, operation, performance and maintenance to ensure reliable, consistent production of water of required quality Operate within design capacity Prevent unacceptable microbial, chemical and physical contamination during production, storage and distribution Quality Assurance involved in approval of use after installation and maintenance work Water system requirements (2) Monitoring of water sources regularly Chemical and microbiological Endotoxin level where relevant Monitoring of system performance, storage and distribution systems Records of results, and action taken Validated sanitization procedure followed on a routine basis Purified Water (PW) Prepared from potable water source Meet pharmacopoeia specification for chemical and microbial purity Protected from recontamination Protected from microbial proliferation Highly Purified Water (HPW) Prepared from potable water source Specification only in the European Pharmacopoeia Same quality standard as WFI including limit for endotoxins, but treatment method considered less reliable than distillation Prepared by combination of methods including reverse osmosis (RO)