Manufacturers of bioprocessing equipment and com-ponents shall allow free access of owner/user and authorized inspection personnel at all times while work on the equipment or components is being performed.The notification of an impending inspection should be mutually agreed to by the manufacturer and the inspec-tor. Access may be limited to the area of the manufactur-er’s fcility where assembly, fabrication, welding, and testing of the specife equipment or components is being performed. Inspectors shall have the right to andit any examination, to inspect components using any examination method specified in the Design Speci-fcation (including Purchase Order)。 and review all certifications and records necessary to saisfy the re quiements of GR-5. The maoufacturer shall pruvide the inspector with work progress updatcs.
