How do you communicate and collaborate with GCP or GMP auditors or inspectors?

Ensure that each of the SMEs have proper understanding of what is needed in the audit agenda. Look out for out of scope process and clarify any concerns to the auditor before the scheduled session.

Ensure you have read the audit agenda in detail prior to the arrival of the auditor. Ensure that area SMEs are available during the corresponding time within the audit agenda. If they are not, communicate this upfront to the auditor, they are usually flexible (within reason). Prepare all site employees for the audit and make them aware of the correct behaviours. Make sure employees prioritise any urgent audit questions on the day over other workload. The audit is not just the responsibility of QA, input from all areas is expected (and much appreciated!).

For any audit, audit agenda will help to make strategic plan for the readiness of Audit. But it may varies according to type of audit. In case of schedule audit we have enough time to prepare but for unscheduled audit we don’t have enough time to prepare for audit.

The most important part of this is to understand what the auditors are looking for. All too often I have seen people jump right to what they think the auditor is looking for and completely miss the mark, which only opens you up to other issues. Take a minute and understand what the request is and don't be afraid to ask for clarification if you are not sure.

Be prepared: Ensure that you are prepared for the audit or inspection by reviewing relevant regulations, guidelines, and documentation. This will help you respond effectively to any questions or requests from the auditor or inspector. Maintain open communication: Establish open communication channels with the auditor or inspector and be responsive to their questions and requests. If you don't know the answer to a question, don't hesitate to say so, but be sure to follow up with the answer promptly.

It is a good practice to have a mock audit at your facility. Going through the procedure in advance of the actual audit will allow you to catch any potential gaps or misunderstandings. This will ensure there will be no unpleasant surprises when the FDA actually shows up.

A 'back room' set-up is invaluable. The back room being a hub outside the audit room where key personnel are set up to manage requests behind the scenes. This creates a professional setup within the audit room and keeps the atmosphere calm. Make sure there is a person in the audit room with a laptop and a means of communicating by chat or email to the back room. This person needs to be experienced in dealing with auditors to fully understand requests and to communicate effectively. Any documentation requests (or potential requests) should be communicated quickly to the back room. A ticketing system can be set up to manage document/record requests and sent into the audit room once fulfilled.

For schedule audit, we can gather and arrange documents in sufficient times according to audit agenda. But for unscheduled audit, on first day documents can be provided on need based and later on we can gather and organized documents based on prediction or provided agenda.

Collaborate on findings: If any deficiencies or non-compliances are identified during the audit or inspection, work collaboratively with the auditor or inspector to address the issues. Ask for clarification if needed, and propose solutions that are practical, feasible, and effective. Document everything: Ensure that all discussions, decisions, and actions related to the audit or inspection are documented in detail. This will help ensure that all parties have a clear understanding of the findings and any actions taken to address them.

Keep answers to the point and factual. Ensure you listen to the questions carefully and answer only the question asked. Never under any circumstances should you lie, never. If an issue is identified, do not try to hide it, accept it and move on. The purpose of the audit is challenge your processes so some issues are expected. A robust QMS will have any identified issues resolved through your CAPA process in due course.

Honesty and truthfulness is main factor in facing audit. Trust should be built in the auditor by providing true, correct and valuable information. It ultimately helps to complete audit agenda within time frame.

One thing I have observed rather consistently in remediation projects, is that the people rush to fix the specific item that is commented on, and they fail to look at the comments holistically. If you step back and look at the Quality System, and how it relates to the specific comment, you may see the overarching source of the problem. The Agencies are not looking to police everything you do, they want to test your quality system maturity to know that you can self regulate and fix the entire issue, and not just the little flag they pointed out.

Follow up: After the audit or inspection, follow up with the auditor or inspector to ensure that any corrective actions have been implemented and that any outstanding issues have been resolved.

Do not rush to resolve NCs on the day of the audit. Take the available time to generate a meaningful CAPA Plan and Robust Effectiveness Check. Better to get it right first time than risk a repeat occurrence. A repeat occurrence could well result in an increase in the criticality assessment of the original NC and possibly a new NC relating to the Effectiveness of your CAPA process.

Listening and responding is good skill that need to be shown by audited. Suggestion, recommendations are helpful for improvement of the process and auditee should positively take this information. An immediate action to given observation is prime factor for building trust by providing commitment to quality.

Appropriate QMS procedure should be followed for providing response within regulatory time frame. On last day of audit, upper management should congratulate their fellow colleagues for sharing learning, opportunity and success of the audit that built confidence in employees.