Auditor field inspection

Any portion of the study that is a "field study" may also be audited. A field study auditor would inspect many of the same items already mentioned, but at the field site location. These include the training and experience of the field personnel, the calibration and maintenance of equipment, the field management and operations, the test substance application, and the sampling. Special problems are sometimes encountered in the field because the site is physically displaced from the main site of the study. Despite the physical displacement, the equipment must still be calibrated and maintained, the protocols and SOPs must be followed, there must be proper record-keeping, and there must be regular inspections by the QAU. 

After a field inspection is completed, any deficiencies found or recommendations for improvement are discussed with the investigator. This is followed by a written report. The investigator then may append any comments he may wish to make to the report. He signs and dates the report then sends it to his supervisor who signs and dates the report and returns it to the Quality Assurance auditor. 

The auditor should verify information by field inspection wherever possible. For example, an operator may have a procedure for carrying out a task, but, when demonstrating what he actually does when working with the plant equipment, may demonstrate that his actions are not in conformance with the procedure. 

Based on technical report 32, PDA has established a third party inspection program in the field of software suppliers. It works like the one described for IPEC s BPE GMP audits. By March 2002, 117 auditors had been certified, and the audit repository center, as the service provider licensed by PDA, lists 22 audit reports [33]. 

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