The announcement of an inspection by the Belgian Federal Agency for Medicines and Health Products (FAGG) or any other external audit within a pharmaceutical company is inevitably linked to extra workload and unwanted stressful situations. However, as a QA consultant at Farma Consultant & Partners, I’ve always viewed this as one of the most enriching and opportunistic periods. During this time, employees can delve into specific topics and finally obtain the necessary resources to implement persistent actions. For this reason, I would like to share my audit experiences, along with some important do’s and don’ts, through this blog.
Preparation is Key – Audit anxiety often increases in the weeks or even months leading up to the actual audit. This preparation phase is crucial for the smooth running of the audit and includes identifying potential gaps, preparing and gathering the necessary documentation, and training all relevant personnel who may need to act as spokespersons. The daily production tours organized during the pre-audit period are very interesting, as they increase the presence of QA in the production environment. The goal of these tours is to identify and eliminate audit-sensitive issues, ranging from housekeeping-related topics such as damage to walls/ceilings/doors to addressing operators’ aseptic behavior/gowning, addressing uncontrolled or incomplete documentation (e.g., logbooks), and checking machines and equipment.
Additionally, it is advisable to conduct a trending analysis of recurrent and audit-sensitive quality incidents from the past few years before the inspection. This allows you to prepare for these topics in advance, for example, using the “5 minutes – 5 slides” principle, so this doesn’t have to be done in the midst of the audit’s hectic atmosphere.
Let the Games Begin – Despite weeks of thorough preparation, everyone is on edge at the start of the audit. During the first few days, auditors will be given a physical tour of the organization, including production departments, QC labs, warehouses, and will closely inspect housekeeping, documentation, equipment, process flows, operator activities, etc. They will share their questions and comments on the spot, which may lead to requests for additional information. These requests should then be communicated to the backroom as quickly as possible so that the relevant experts can begin preparing the requested information.
While these tours usually take place under the guidance of management, as a QA consultant, you can also play an important role as a ‘sweeper.’ The goal of sweeping is to walk about 10 minutes ahead of the actual audit tour and perform a final check of the respective areas. Requests may also arise after reviewing documentation. For example, they may request a list of quality incidents, as well as qualification and validation reports/protocols, batch records, complaint records, SOPs, logbooks, site master files, registration files, and previous audit reports. This means that any GMP-related document can be subject to the audit. Therefore, it is essential to keep all these documents up to date and ensure proper Good Documentation Practices (GDP).
Backroom vs. Frontroom – All requests are then gathered in the backroom, from where they are communicated to the various spokespersons. The backroom is the heartbeat of the audit and aims to ensure that everything in the frontroom runs as smoothly as possible. However, it is impossible to create a fixed schedule in advance because the auditor decides which requests to call up. Therefore, it is important for each spokesperson to prepare their request as quickly as possible and be ready at all times to present it in the frontroom to the auditor. If in doubt or for a first-time auditor, it’s a good idea to have your request filtered by a colleague or manager. Based on the feedback and questions received, gaps may be identified that can be closed before heading to the frontroom.
Where there is often chaos in the backroom, the frontroom is peaceful. In addition to the auditor, there is a host and scribe here, who manage the communication from the frontroom to the backroom. Before starting your presentation, briefly introduce yourself and your role within the organization, and then proceed to the presentation of the actual request. While no advice guarantees a successful interaction with the auditor, there are some undeniable do’s and don’ts:
- Always take the time to understand the auditor’s question to avoid answering off-topic. Don’t hesitate to ask for additional information if the question is unclear or too general.
- Prepare thoroughly and ensure that you can quickly provide all necessary documentation. Bring hard copies of related procedures/reports and make sure you are already logged into the required software programs on your computer.
- Answer concisely but comprehensively, without unnecessary extra information or details. The more information you share with the auditor, the more additional questions they can ask.
- Communicate in a calm and confident manner. Given the thorough preparation, you are the expert in the relevant topic.
- Provide facts, not opinions or assumptions. Base your answer on existing procedures, documentation, and processes. If the answer is not known, honestly state that it needs further clarification and you will come back to it later.
- Assume that the auditor is not an expert in the particular product or process. Therefore, always provide enough background information.
- Don’t use language that makes you appear uncertain, such as ‘I think,’ ‘usually,’…
- Avoid arguments with the auditor. If you disagree, you can always share your concerns with the backroom, and further actions can be taken in consultation with management.
- Don’t question the accuracy of the information provided by a colleague in the frontroom to the auditor. If necessary, this information can be corrected at a later time.
- Avoid small talk with the auditor, especially about audit-related topics. During the audit, nothing is off the record.
- Turn off all notifications from platforms such as Teams or email to prevent pop-ups during your presentation in the frontroom. Giving the auditor insight into messages circulating in the backroom is a recipe for disaster.
There is no blog or guideline that comes close to the learning curve gained from personal hands-on audit experiences. Still, hopefully, the above outline of the audit process and the accompanying tips & tricks will set you on the right path for your first audit. Do not hesitate to contact me or one of my colleagues at Farma Consulting & Partners for more audit-related questions.
Author: Jonas Van Dingenen – QA Consultant
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