• Joe Winslow

How to prepare for a cGMP Audit


In my career, I have probably participated in scores of GMP audits in various roles and from various perspectives. I have been the auditor, the auditee, a system owner, I have helped prepare for audits, I have been asked to come in after an audit and give my opinion on the findings, and been asked for help in correcting those findings or responding to them. I have been a VP in charge of ensuring successful audit outcomes. These audits have been from the FDA, the European Union, Health Canada, and various other authorities including Korea, Japan, Brazil, and Australia. I have participated in audits from pharmaceutical clients both big and small. In short, I have learned a lot over my career about how to prepare for a successful GMP audit. Here are some key points.

BioPharma companies should continuously be prepared for an audit. When the FDA comes in for a general cGMP inspection, they are going to look at 6 systems if they have time to do a complete and thorough job. Those 6 systems are:

  1. Quality

  2. Facilities and Equipment

  3. Materials

  4. Production

  5. Packaging and Labeling

  6. Laboratory Control

Internal audits should ensure that all of these systems are in order and under control. Each of them have numerous sub-systems that are vital to ensuring a process that is under control. Be sure the findings of internal audits are corrected or there is a plan in progress to correct them before your official audit.

It is difficult, if not impossible, to describe in detail all of the components that need to be looked at in this short article. A day long class could easily be filled with content on this item alone (more on that later).

In addition to ensuring your GMP systems are in a state of control, the personnel from your company also need to be coached on interacting with the inspectors. Truthful, succinct, accurate courteous answers should be the norm and nothing should be guessed about or speculated on. If an answer is not known, that should be stated, and if something is documented in an SOP, that SOP should be referenced when giving the answer. Personnel who don’t often deal with audits can get nervous, so the information above should be given to them early and often.

The core team from the company who will be interacting with the auditors should be identified. There will most likely be one person from each of the 6 systems noted above to answer questions from auditors about that system. In smaller companies, more than one of the systems may be covered by one system owner. This team should be readily available at all times during the audit, while recognizing that they also have a full time job. These are the people who will know in general how their department handles things, which SOP’s are pertinent to answering auditors questions, and who the experts in their departments are in case the auditors want to take a deeper dive into a particular topic. They will also know where the vulnerabilities are in those systems and should be prepared to talk about those vulnerabilities if the auditor discovers them.

First impressions play a big part in any successful human interaction and audits are no different. It starts from the first communication you have when scheduling the audit, if you get that chance, or when the auditors show up at your front door if you don’t. Courtesy and professionalism should go without saying, but I have heard stories of CEO’s making the FDA wait in the lobby because they weren’t ready to deal with them when they showed up unannounced. This obviously is an egregious example, but not unheard of. First impressions often start with the receptionist. Most of the receptionists I know were selected because they were pleasant, happy people, but there are obvious exceptions that we can all think of. Make sure the receptionist knows what to do if auditors show up and has a pleasant demeanor.

The facility should always be in audit ready condition. This includes items associated with upkeep i.e. paint, housekeeping, cleaning, etc., but also with the general feeling you get when you tour. Do you get a feeling that everybody is moving at a frenetic pace, or that they are standing around gossiping instead of attending to their job? Are items neatly stored where they belong and are they labeled appropriately and legibly? In other words, are things running like a fine Swiss watch or a cheap knockoff?

If there is construction going on, the default action of every company that I have worked for is to stop all work while the auditors are onsite. This prevents the auditor from running into a construction worker who probably doesn’t know GMPs very well and getting a bad impression. It also reduces the risk of an auditor witnessing any breach in the construction separation walls or any non-compliant actions by the contractors. I tend to disagree with this approach. To me, it shows the auditor that you may have something to hide. I would rather keep the construction activities going as long as the noise is not disrupting the audit. This construction should be very closely supervised by well trained personnel to make sure everything stays in compliance. As a caveat, I should say that I am definitely in the minority with this opinion.

Even the conference room where they auditors will be sitting during the audit can play a part. I once participated in an audit where the auditor was very unhappy with the initial conference room where he was seated and it started the entire audit off on a very uncomfortable foot. Water and coffee should be available with restrooms nearby that do not allow or require the auditor to walk through office, laboratory, or manufacturing areas on their way to and from them.

A “war room” should be available for internal Subject Matter Experts (SMEs) and QA personnel to use to review documents prior to providing them to the auditor. This room should be in proximity to the audit conference room, but not so close that conversations can be overheard. The document review will make sure that the document is the correct one that answers the auditor’s question and is most the most current version. It will also uncover any additional supporting documents that might be needed before you go in to discuss the issue with the auditor. This room also allows the QA personnel to discuss the auditor’s questions with the SME to give them the proper context and give them some indication of what they auditor is trying to find out. This helps the SME be better prepared and give the impression to the auditor that they are totally prepared and their system is in a state of control.

Preparing for an audit can be an arduous task if you don’t keep your systems in a constant state of compliance with GMPs and your own SOPs. If you are in compliance at all times and you don’t procrastinate correcting systems you know are broken, closing investigations in a timely manner and ensuring your Corrective Action/Preventive Action programs are effective, then audits can be much less stressful.

JW Consulting Engineers and Terrang Consulting will be teaming up to teach a class at Cleanroom World in Centennial, CO on November 1st that will go into this topic in much more detail. This class will include a hands on mock audit in a real clean room. If you are anticipating an audit, this class will make you much more prepared for it. Sign up now by clicking here


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