Conducting the Audit - Ready or Not, Here They Come - - BioPharm International


Conducting the Audit - Ready or Not, Here They Come

BioPharm International

Sample Contact List
Preparing a list of internal contacts is the first action item in the operation plan (see the "Sample Contact List" box). The list should identify the person who is most knowledgeable in particular business areas or about particular projects (for example, the individual responsible for training programs or the person managing validation projects). For instance, if a new system has been validated and placed in service recently, identify the key individual or project manager on that system. Or if there has been an investigation because of a failure, identify the key person who followed through on that investigation and the person who prepared the appropriate documentation.

Once a complete list of internal contacts has been created, have each individual contact prepare a list of people they worked with who were responsible for specific project details. If a new system has been implemented, the individual contact list would identify the project engineer, the QA person, and the validation person who implemented the project; or an investigation into a failure would identify the area manager for the unit in which the failure occurred, the QA individual who approved the plan of action, and any other staff who had either direct or indirect interaction with those activities. Substitutes should also be identified because some people may be unavailable on short notice.

Next, make sure that each person is alerted that an inspection is being conducted and that they may be needed to respond to questions. List and verify all contact information including work, home, cell, and pager numbers. Email addresses are also helpful. Request that those individuals identified outline their areas of responsibility, review the relevant documents, and remember major events such as lost batches or emergency shutdowns. If any documents are stored at an off-site facility (such as a corporate office or a storage center), transfer them or alert the other facility to have them available for quick access. The individual contacts must be trained to handle an interview with an inspector. They should be instructed on what to say and how to say it. If two or more people were involved in resolving an issue or worked together on a particular project, interview them to make sure their stories coordinate with one another.

Prepare work environments. With any FDA inspection, two rooms need to be designated for the audit. The first room is the inspectors' room, in which the inspectors conduct the audit. Make sure that room is clean and has general office supplies, a phone, coffee, access to a rest room, and a place for the inspectors to take a break. The room should be comfortable, but don't go overboard providing amenities. Inspectors are not allowed to accept gifts. When selecting the location for the inspectors' room, don’t choose one too close to the manufacturing facilities. That will help prevent interruption of day-to-day activities and operations. Inspections can be interruptions, but employees should be encouraged to continue to be productive.

The second room is often referred to as the war room. The war room is typically an assigned area beside or across from the inspectors' room. The war room is a staging area in which employees can respond to the inspectors' requests for information quickly and effectively. The purpose of this room is also to control traffic into and out of the inspectors' room. Anyone going into the inspectors' room must first pass through the war room. It should be equipped with the same supplies as the inspectors' room with the addition of a copy machine, computer equipment, and a printer.

Identify and train key personnel. Three roles are necessary to guarantee an inspection runs smoothly. We will call them the war room commander, the war room clerk, and the inspection reporter.

The war room commander is responsible for overseeing all activities in the war room. At any one time, there can be several different requests (for documentation or to speak with different employees, for instance). It is the sole responsibility of the war room commander to contact employees and to collect documentation in response to those requests. When employees arrive in the war room, the commander reviews their documentation and provides last minute coaching on the types of information that the inspector will be asking for.

War room clerks are responsible for assisting war commanders with their duties. War room clerks are typically administrative support personnel. It is their responsibility to make copies and track all documents entering the inspection room. They also conduct other general administrative tasks such as answering the phone and maintaining a meeting calendar to ensure all necessary personnel are available for sessions with the inspectors. Depending on the size of the company, there might be one or more war room clerks assisting with an inspection.

The inspection reporter is essentially an observer and a note taker. The reporter is responsible for recording everything that is said and requested by the inspectors. As the reporter records information, requests are relayed to the war room. Depending on the size of the inspection and the number of inspectors present, there can be many requests made each day. A good rule of thumb is one reporter for each inspector.

These three necessary roles ensure an accurate and efficient response to inspector requests. Remember, one thing an inspector is measuring is how quickly and thoroughly the audited company responds. Inspectors document everything, and they do not forget that a requested document or person was not supplied by the time the audit concluded.

Preparing inspection documentation. Everything that occurs during an inspection should be documented. Invest some time in preparing forms to make the process easier. Once those forms have been created, they can be reused during future inspections.

Inspection Request Form
A request form is the primary form that should be created for an inspection (see the "Inspection Request Form" box, above). Request forms keep track of what an inspector is requesting, when it was requested, who was contacted, and what documents or items were inspected. The inspection reporter is typically the person who initiates the form. The form can be preprinted, emailed, or printed out and is usually sent to the war room. In the war room, the war room commander and clerks complete the request.

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