Comprehensive DOCUMENTATION should be available to define, support and record the overall validation process (See Section 12).The process should be REVALIDATED at intervals (See Section 11).When appropriate attention has been paid to the above, the aseptic process may be validated by means of "MEDIA FILL", (or "PROCESS SIMULATION") studies (See Sections 9 and 10).All processing equipment should be properly INSTALLED, QUALIFIED and MAINTAINED (See Section 8).Assurance that the Clean Room environment is as specified should be secured through initial commissioning ("Qualification") and subsequently through the implementation of a program of re-testing, in-process control and monitoring (See Section 7). Suitable CLEAN ROOM FACILITIES should be available, in terms both of the "local" and "background" environments.Suitable TESTING FACILITIES, EQUIPMENT, INSTRUMENTS and METHODOLOGY should be available (See Section 6).All data generated during the course of the studies should be formally REVIEWED and CERTIFIED, as evaluated against pre-determined criteria (See Section 5).Both the personnel conducting the studies, and those running the process being studied should be appropriately TRAINED and QUALIFIED and be suitable and competent to perform the tasks assigned to them (See Section 4).E) The nurse uses friction motion when washing for at least 15 seconds. D) The nurse keeps hands higher than elbows when placing under faucet. C) The nurse uses approximately two teaspoons of liquid soap. As a pre-requisite, all studies should be conducted in accordance with a detailed, pre-established PROTOCOL, or series of protocols, which in turn is subject to formal change-control procedures. B) The nurse washes hands to one inch above the wrists.
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