| As a regulatory body, the U.S. Food and Drug | | | | therefore, it is essential to have the most up-to-date |
| Administration (FDA) inspects organizations involved in | | | | and comprehensive quality manual for the entire |
| the manufacturing of drugs, biologics, and medical | | | | facility. Procedure manuals must be easily accessible |
| devices. Many of these regulations enforced by the | | | | and distributed to all key personnel so that any |
| FDA affect clinical and laboratory sites by applying | | | | questions raised during the audit may be answered |
| best practices such as good laboratory practices, | | | | by your team. |
| good clinical practices, human subjects' protection, | | | | Train appointed personnel to accompany the |
| and requirements for institutional review boards. FDA | | | | investigator and conduct employee training prior to a |
| investigations are carried out in the same process | | | | live audit |
| whether they are inspecting a large manufacturing | | | | Electing at least two or more representatives to |
| site or a small laboratory. For a small facility, an FDA | | | | accompany the FDA investigator will ease the |
| inspection is often challenging if the quality team lacks | | | | pressure of this responsibility on a single person. The |
| experience and resources, however, a clear | | | | selection criteria of the representatives who will |
| understanding of the inspection process and | | | | accompany the investigator must be based on their |
| structured approach to inspection preparation can | | | | knowledge, ability, expertise relative to the processes |
| reduce the uncertainty of success of the final | | | | and must be trained to interact with the investigators |
| inspection. | | | | as well as be familiar with the inspection policies. Once |
| Five ways to prepare for an FDA Inspection | | | | the representatives have been chosen based on |
| The preparation for an FDA inspection must start | | | | these important qualifications, they should then train |
| long before the actual scheduled inspection day in | | | | the employees who will be impacted by the |
| order to demonstrate that your organization invests | | | | inspection in general inspection policies and expected |
| in both high quality and process improvement – | | | | conduct during the inspection. Training others can be |
| essential to impress regulatory authorities. Here are a | | | | a great way of assimilating important messages and |
| few ways in which your organization can prepare for | | | | clarifying common doubts prior to the live inspection |
| your next FDA inspection: | | | | conducted by the FDA investigator. |
| Conduct internal mock audits | | | | Prepare Standard Operating Procedures (SOP'S) for |
| Although a mock inspection cannot fully prepare you | | | | the inspection day |
| for the actual inspection, it will help you identify the | | | | Before the inspection day, you must create an |
| weak spots in the procedures and put you in a | | | | operating manual detailing the following: |
| better position to revise them in accordance with the | | | | - Conduct and behavior |
| FDA regulations. The mock audit also provides an | | | | - Roles and responsibilities |
| opportunity to learn from the mistakes, anticipate | | | | - Document retrieval processes |
| questions that might be asked, and train the key | | | | - Actions permitted during inspection |
| personnel who are directly involved in the actual | | | | - Documentation of inspection findings |
| inspection. | | | | - Inspection follow-up and response procedures |
| Analyze risks and take required actions on | | | | This manual must be distributed to all those involved |
| non-conformances | | | | in the inspection well in advance so that they may |
| Since the FDA investigators thoroughly inspect every | | | | clarify any inconsistencies and appropriate revisions |
| process, conducting an internal audit will help you | | | | can be made prior to the live audit. |
| identify potential risks in your processes and provide | | | | Conclusion |
| an opportunity to take the required corrective, | | | | Going through an FDA inspection is not something |
| preventive, or improvement actions to resolve | | | | many companies look forward to as it requires a |
| non-conformances raised during an internal audit. | | | | great deal of commitment and an allocation of |
| Focusing on key problem areas and how they link | | | | resources prior to the actual inspection day, |
| with each process will help improve the processes | | | | however, being prepared for an FDA inspection will |
| that might draw negative attention from FDA | | | | not only help you pass the inspection with low |
| investigators. | | | | negative outcomes but will also boost the confidence |
| Easy access to the current quality manual | | | | of your quality team. Regular review and |
| Efficient documentation is the basis of a successful | | | | improvement of processes helps organizations in |
| FDA investigation. Inspectors will always ask for | | | | improving their preparedness for an inspection. |
| procedure manuals to review for each department, | | | | |