Is Your Lab Ready for Audit?

Questions to Ask Yourself to Ensure Your Lab is Ready for Audit?

You have been notified that your lab has been selected for an audit by a Sponsor of your GLP studies. How can you best prepare for their arrival?

Below are some key questions to ask yourself to help prepare your lab for the audit and ensure everything is in order when the auditors arrive.

Have you read the audit plan?

Before the audit, the auditors will typically send an audit plan detailing the standards against which they will be assessing your facility. This is your chance to prepare yourself for their expectations and let them know if you don’t conduct any of the activities that they have included. For example, have they included GCP regulations when you don’t conduct any clinical trial analysis? These situations can arise during qualification audits if there have been any miscommunications during the vendor selection discussions; then this is your opportunity to clarify this ahead of their arrival.

Are the subject matter experts available?

While preparing an audit agenda, ensure the subject matter experts are available for interview. Just because you are hosting the audit doesn’t mean that you need to have all the answers but knowing who to contact to find the answers is essential for ensuring a smooth audit process and keeping frustrations to a minimum. If there is a period when many of the experts will be on leave, discuss this during the audit scheduling and request alternative dates when staff will be available. If you have any processes that are predominantly performed by global colleagues who are in different time zones, communicate this to the auditor to enable their session to be scheduled within their time zone, where possible.

Have they requested any documents in advance?

Auditors typically request a list of documents that they would like to review ahead of their arrival, which may consist of high-level standard operating procedures, quality manuals/policies, certificates from regulatory inspections, contracts if there are any in place, and if any work has been conducted for them, deviations for their studies. By providing the documents in advance, you allow the auditors to familiarise themselves with your systems and practices, helping the audit move more quickly once the auditor has arrived on site. If it is not possible to provide documents in advance, let the auditor know. If you are providing documents, make sure you are providing the most up-to-date versions, and not just reusing the documents from the previous audit you hosted two years ago.

Do you know where all their data is?

As a GLP facility, you will have a comprehensive list of the studies you have conducted for the Sponsor. Your archiving indexing system should enable you to locate any data that is still retained, determine if any data has been sent back to the Sponsor, and which studies are still ongoing. Within the audit plan, there will likely be several studies included in the scope; at a minimum, ensure you know the location of these so that they can be made available during the audit. You don’t want to be in a position where you tell the Sponsor that you don’t know where their data is, only to find it later and need to backtrack. This could make them question the control you have over your archive and how secure their data is.
Are you up to date with all the applicable regulations in the audit plan?

Does your lab have a process for implementing new regulatory requirements?

The auditor may want you to be able to demonstrate that you have reviewed your processes against any of the new regulatory requirements and have a process in place for tracking any required updates. OECD Document 25 has been issued recently – does your facility comply? Have you reviewed your processes against Supplement 1 to Document 17, and how has your company approached continuous improvement as recommended in Document 24? Be prepared to demonstrate to the auditor that your lab is keeping up to date with the current and historical industry requirements.

Are your staff prepared?

It’s natural for people to get stressed or nervous about a client audit, but letting your staff know in advance that an external visitor is coming can help them prepare themselves. Let them know that if they are asked a question on the tour, it is ok to say that they need to consult the procedure. It’s better to consult the procedure rather than give an incorrect answer – that is what the SOPs are there for. It also provides an opportunity to demonstrate how SOPs or Study Plans are available at the point of use.

Are you ready to respond to findings and provide corrective actions?

Following the audit, there may be findings (or there may not be). The auditor should discuss potential findings in the closing meeting of the audit, and these should be against the regulations that have been stated in the audit plan. When completing your responses, ensure that you are responding to the finding and including enough detail that the Sponsor can see what you have done to correct the issue, but also what you have done to prevent it from happening again. Include due dates and document reference numbers, and if any internal deviations or CAPA plans have been raised, include these references as well. This will help at the next audit when the Sponsor’s auditor requests to see evidence of actions from the previous audit.

Hope you find these tips useful, and best of luck during your next audit! Taking the time to ask yourself these questions in advance can help ensure your lab is well-prepared and that the audit runs as smoothly as possible.