Audit room inspection

Once the inspectors have entered the audit room, they are greeted by the representative of the management. Then, the exchange of business cards and personal presentation follow. The other participants introduce themselves as well as the management representative and hand over their business cards. This usually happens before the inspectors have taken a seat. After the inspection, the business cards are a valuable source of information on names and functions of the contact persons who participated in the inspection. It is common that the inspectors identify themselves to members of management with their identity card credentials and thus begin the official part of the inspection. 

Presentation of the audit core team (persons in the audit room are direct contact persons during the inspection)... 

After agreement on the contents of the inspection, a little break to drink coffee, tea, or soft drinks can be used to give the participants who do not belong to the core team of the audit room, the opportunity to leave the room. 

The audit room is the room, in which the inspectors and the core team stay during the inspection and where the documents and records are reviewed by the inspectors. This is also where the opening meeting and the closeout meeting take place. The management or management representatives must be present both at the beginning and at the end of the inspection. 

The back office is the communication center in the background of an FDA inspection. Here, all information from the audit room about the questions or needs of the inspectors is gathered. These requests can be reported to the back office, either directly from the audit room or during the company-walkthrough. All documents, records, or samples requested by the inspectors shall be verified first in the back office and then transferred to the audit room. Similarly, the persons who have to present issues of their field of responsibility in the audit room will be prepared in the back office (briefing). These persons are kept ready and wait in the back office until they are called by the note-taker of the audit room to present their topic. These activities are to be documented by the note-taker in the back office tracking fist. 

Most of the inspection time is usually spent in the audit room. The attendees shall deliver documents, records, procedures, and processes, on request... 

Plant HP Emergency Equipment Audit," which has not been reviewed by the staff. In addition, EPIP 6Q7-303 identifies maintenance and inventory requirements for first-aid equipment to be in accordance with the Medical Department Manual 3Q-7, "First-Aid and Nursing Procedure 4008," and "Checking Treatment Room and Stocking Emergency Cabinet," which have not been reviewed by the staff. EPIP 6Q7-303 also addresses inventory and inspection, of rescue and radio equipment. 

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