A Comprehensive Guide to your FDA Audit Preparation

Quick Tips to Prepare for an FDA Inspection

Pre-Inspection Preparation Process

To facilitate a smooth FDA audit, it is essential to designate a knowledgeable person as an escort who will oversee the inspection process. The escort plays a vital role in monitoring the FDA investigator's activities and acts as a guide and a general point of contact for the study. By assigning someone to this role, companies can maintain control over the inspection proceedings and ensure that the investigator receives the necessary information in a regulated manner.

Additionally, it is advisable for companies to wait for specific requests from the FDA before providing any information, as this helps maintain a focused and organized approach to addressing the FDA's inquiries.

Develop a Standard Operating Procedure (SOP) for Managing FDA Audit Preparation

The SOP should include clear instructions on whom to contact first when the inspector arrives at the site. It is recommended to notify the facility's quality lead and the site operations lead, along with their backups. By establishing a designated point of contact, the facility can ensure a prompt and organized response to the inspector's arrival.

How to document FDA requests for information should also be addressed. It is essential to establish a standardized process for recording and tracking these requests to ensure accuracy and traceability. The SOP should provide guidelines on handling the inspector's requests for photographs or videos. Predetermined protocol can ensure companies that these requests are addressed in a controlled manner, while maintaining compliance with applicable regulations and policies.

Create an Inspection Readiness Team

It is advisable to establish an inspection readiness team consisting of members from the quality organization as well as cross-functional groups. Their role is to identify and complete activities, providing support throughout the inspection, this way ensuring a comprehensive and thorough FDA audit preparation and increasing the chances of a successful inspection outcome.

Predetermine Workspace Rooms for Inspectors and Audit Support

It is also recommended to predetermine and allocate specific workspace rooms for the inspectors and audit support. The FDA representative's workspace should be located away from heavy traffic areas to provide a conducive environment for their work, the same must be true for the support room (that should be situated in a separate location from the FDA representative's).

This separation minimizes distractions and noise that may arise from the other room's activities, allowing the inspection process to proceed smoothly and without interruptions.

Predetermine the Presentation Person

Mock-up sessions may bring opportunities for the Quality Manager to select the right person for presenting information for the FDA during the audit. By defending SOPs, deviations, trend reports and validation, the management can understand who among the team is skilled for presenting in a complete and confident manner.

Identify Records FDA Are Likely to Inspect

Good organization of documents plays a crucial role in ensuring successful FDA audit. To prepare for such inspections, it is important to organize all regulatory files in a clear and systematic manner. This can be achieved by categorizing the documents under appropriate general headings and arranging them in either chronological or reverse chronological order.

By visually presenting the documents in an organized fashion, it promotes confidence in the inspector that the cGMP (current Good Manufacturing Practices) documentation practices are being implemented and followed. Additionally, providing well-written summaries can greatly simplify the inspection process. Inspectors may prefer concise and informative summaries over bulky and complex documents, as they offer a clear overview of the information presented.

Develop a Strategy That Justifies Decisions Made

These could include validation reports with numerous deviations and discrepancies or deviations that require a robust justification. When these "hot topics" are identified in advance, you can allocate resources and time to develop a solid defense strategy.

Defending decisions requires careful forethought and practice, especially when it comes to effectively articulating data and drawing conclusions from it. Regular practice and rehearsal of the defense strategy are key to ensuring that the team is well-prepared to address any concerns raised during the inspection process.

What You Are Expected to Do During the FDA Inspection

As soon as the inspector arrives, it is important to document their name, as well as the date and time of their appearance. Next, the quality head, operations head, and their backups must be notified about the regulatory inspectors' presence. Once the initial introductions are made, the inspector will present their credentials to confirm their authority.

In the subsequent opening meeting, it is necessary to gather information regarding the type of inspection that will be conducted. This distinction is crucial as the approach for a "for cause" inspection differs from other types of inspections.

Exit Interview

At the conclusion of the FDA inspection, an exit interview is typically conducted by the inspector. It is important to inform the relevant individuals, such as the escort, quality head, operations head, backups, and a representative from Institutional Compliance, about the time and location of the interview.

If significant deficiencies are identified during the inspection, the regional office will send an Inspectional Observations Form 483, which outlines the identified deficiencies. Both the quality head and the investigator should ensure that all information discussed during the interview is clear and well understood. Any observations, comments, or commitments made during the interview should be documented in the escort inspection notes.

Following Up

If a Form 483 is issued, it is necessary to prepare a written response that specifically addresses the identified issues. Determine whether the finding was an isolated incident or a systemic problem and outline the corrective actions that will be taken. Justify why the proposed response is expected to rectify the issue and provide a reasonable timeline for completion. If the quality head disagrees with any observation, respond with factual and verifiable evidence.

Each finding should be addressed point by point in the response. The company has two weeks from receiving the Form 483 for submitting a reply.

Eclevar Keeps Track of Your FDA Audit Preparation

Partnering up with a competent CRO like Eclevar offers you the certainty that your research and documentation needs will be addressed in the most appropriate and careful manner. Our team of experts work alongside your personnel to make sure your regulatory aspects comply entirely with the guidelines of the major agencies around the world.