Successfully managing a cGMP inspection begins first with developing a clear-cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection. Because the FDA can arrive at your company without any prior notification, it is important that you thoroughly, and regularly train and prepare all personnel, so they will be ready to act if an unannounced inspection takes place. But how do you thoroughly plan and prepare your company for a cGMP inspection audit, and what do you do if they show up one afternoon at your front door?
The FDA inspector must present some form of notice of inspection (FD-482), and should offer proper FDA credentials upon your company’s request. If the FDA inspector cannot supply you with the proper credentials, then it is within your company’s legal right to not begin the investigation until the person can authenticate their FDA status. Any persons accompanying the investigator should be able to provide proper identification as well, and also explain their purpose for requesting entry and authority to enter your premises. Upon presentation of these formal documents, entry cannot be refused as long as it’s under normal business hours.
Once the inspectors have been verified, your company representative shall notify a designated individual, who will then notify all the relevant managers and department heads and let them know that there is an FDA inspector on the premises. Once you are ready to begin the FDA inspector will notify your company the exact purpose for the inspection, and roughly how long it will take for them to complete their audit. You will want to supply the inspectors with an office room, or conference room so that they can set up a base of operation, and review their records and files.
The inspection itself usually involves a combination of physical plant inspection, as well as possibly document and record review. This may also include any recent complaints, production records, and possibly storage and shipping records as well. All employees should cooperate with the investigation in any way they can while assuring that their conditions meet your proper code of conduct that you have set forth. Your company representative must accompany the investigator at all times during his investigation, as well as keep detailed notes, including record of dates, times, areas inspected, questions or remarks from the investigator, and any observations made.
Your best chance of having a successful cGMP inspection is to thoroughly prepare for it. Even if the audit is unannounced, your company and personnel should know exactly what protocol to have, and a plan already in place. The best way to prepare for a cGMP inspection is to first hire an outside pharmaceutical consultancy firm that can help your company to make the adequate preparations. They will be able to thoroughly guide your company on the best course of action your company can take, and teach you how to properly put them in place.
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