What you need to know for your FDA Audit Preparation?
One of the top concerns about FDA inspections is the lack of preparedness and uncertainty about what to expect. Addressing these concerns begins with gaining a comprehensive understanding of how to prepare for an FDA inspection.
It is crucial to develop an inspection readiness plan that outlines the necessary steps to be taken before, during, and after the inspection. This proactive approach not only alleviates concerns but also enhances confidence in the quality system among the inspectors. By following the guidance provided in this article, companies can ensure proper understanding to face an FDA Audit Preparation, thereby mitigating potential issues and demonstrating their commitment to compliance.
Quick tips to prepare for an FDA inspection
- FDA inspection procedures must be clear and concise
- Documents and records should be easily accessible
- Labelling items for fast retrieval to save time
- Compile product complaints and CAPAs
- All corrections or recalls should be disclosed
- Mock FDA Audits can ensure preparedness
What you should pay attention to in the 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 the 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 the 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 informations 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 this “hot topics” are identified in advance, you can allocate resources and time to develop a solid defence 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 defence 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’s 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.
When the Audit actually starts
- Make sure the inspector is escorted to the designated conference room.
- Remove any confidential records from their workspace and accompany them during document reviews.
- Notify the entire site about the ongoing inspection and set up an audit support room with necessary equipment.
- Provide an introductory presentation on the organization, facility layout, and conduct a facility tour on the first day.
- Keep a copy of the facility diagram available and address any housekeeping issues beforehand.
- Log and promptly deliver requested documents, seeking clarification when needed.
- Debrief with the inspector daily to anticipate future directions.
- Provide requested files and maintain an inspection record log for copied documents, marking them as “Confidential”.
- Do not grant access to unauthorized records or allow photography without duplicating the images.
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 of 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 personal to make sure your regulatory aspects comply entirely with the guidelines of the major agencies around the word. Contact us and let us help you with your FDA Audit Preparation.
