During the Inspection

To a large extent, success or failure is dependent on the skills and capabilities of the PAI coordinator / moderator and the standard of a company’s backroom organisation. It is important to have at least two separate rooms set aside for the inspection. The front room is used by the inspectors and the second room, often referred to as the “war room” or backroom, is used to ensure that documents are quickly and efficiently retrieved and guarantee the smooth flow of both personnel and documents to the inspection room.

The war room / backroom coordinator and his or her assistant must have clearly defined roles. The same applies for the inspection front room, where the coordinator moderates the inspection and the inspection observer (scriber) takes notes. Each individual request from the inspector should be written down on an inspection request form that notes the date, time, inspector’s name, subject and the requested information. This form should then be taken to the backroom for preparation or investigation by a designated person (runner). Documents such as validation master plans, protocols and reports, batch records, SOPs and other key quality documents should be collected prior to the inspection and made available in the backroom.

It is extremely important that documents are brought to the attention of the inspectors in their original form only (with original signatures) or alternatively as copies that are officially sanctioned in line with your document control procedure.