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The control of water quality, including microbiological and chemical quality, throughout production, storage and distribution processes is a major concern. Unlike other product and process ingredients, water is usually drawn from an on-demand system and is not subject to testing and batch or lot release prior to use. The assurance of water quality to meet the on-demand expectation is, therefore, essential. WHO Document

The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of harms to the product and individuals, according to guidance issued 14 May by the WHO Prequalification Unit – Inspection Team (PQT/INS). Recognizing that the impact of the coronavirus and associated governmental and public health measures vary by country and region, the guidance specifically addresses regulatory expectations and permitted flexibility during the pandemic. Inspections WHO PQT/INS will consider waiving or postponing a routine site inspection for organizations that have already been inspected, pro...