Filling equipment, qualification

In the second edition, 64 new validation SOPs are added to describe documentation required for sterility assurance, qualification and requalification template reports of major sterile equipments, critical applicable procedures, templates for certification guidelines, media fill procedures, environmental control guidelines, training, and critical environmental performance evaluation procedures. 

For example, a company which experienced a customer complaint involving a large glass fragment in an aseptically filled powder vial introduced procedural preventive measures but concluded that the issue required automated vision inspection equipment. Once the corrective equipment was identified, a validation master plan detailed the key qualification elements for hardware, software, defect detection system, infeed/outfeed links, but also the specification requirements of the component and component quality, e.g ... 

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