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The document provides guidance from the CDC on conducting an Operational Readiness Review (ORR) within the Public Health Emergency Preparedness (PHEP) cooperative agreement. It outlines the purpose, structure, and evaluation criteria used to assess whether public health systems are prepared to respo
...
nd effectively to emergencies. The guidance describes required capabilities, review processes, and documentation expectations, helping jurisdictions demonstrate their readiness and identify areas for improvement in emergency preparedness and response.
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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,
...
which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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