It’s critical for pharmaceutical, medical device, and biotech companies to always be ready for an announced or unannounced inspection by the FDA or any other regulatory agency.  

The best way to stay prepared is to have an action plan to maintain a state of continuous inspection readiness, and an effective inspection readiness team that is responsible for implementing the plan. In this piece, we outline the roles and responsibilities of your inspection readiness team. 

What Needs to be Part of the Inspection Readiness Action Plan? 

There are several key objectives of your inspection readiness plan.

One of the essential components of inspection readiness is to have a Quality Management System (QMS) that is current, complete, and compliant. The QMS helps ensure and document that all quality systems are in control and that all processes are being managed in accordance with requirements. 

It’s imperative to have relevant quality metrics that are being used to effectively track and analyze all aspects of your quality program. This will help you identify any areas of potential concerns or questions that may come up during an inspection. 

Another key to inspection readiness is to maintain a file of documents required for inspections pulled together at all times. This file should be reviewed at regular intervals, and must include things such as organizational charts, quality metrics, company history, product information, and training requirements. 

It’s also critically important to identify the team that will be activated during an actual inspection, from the Quality Assurance (QA) Inspection support team to Subject Matter Experts (SMEs) needed to the inspection logistics team. Additionally, all company personnel must be trained to be inspection-ready and know how to interact with inspectors at any time.  

Who Do You Need on Your Inspection Readiness Team?  

So, who do we need on the inspection readiness team to ensure these objectives are met, and what are they responsible for? 

1. Quality Assurance Experts.

Begin by identifying the Quality Assurance (QA) experts who will be leading the inspection readiness activities. Your QA team is most familiar with your QMS and with any open issues that have been identified during quality management reviews or mock inspections. During an actual inspection, the QA lead will be the main point of contact with the inspector and will facilitate face-to-face interviews, discussions, and meetings throughout the process.  The QA team will also lead any gap assessments and mock audits that are used to identify potential problems or issues, so they can be addressed prior to an expected regulatory agency inspection. QA will be responsible for ensuring that Quality Improvement and remediation actions previously identified have been properly addressed and closed out. 

2. Inspection Readiness Training Team.

Another important part of inspection readiness is defining and implementing Inspection Readiness training. This is usually the responsibility of QA but may also involve the company training department. This training should include a brief overview of why the FDA is coming to the site, acceptable behaviors while the inspectors are on-site, and how to interact with the inspectors. And, because you may or may not be notified prior to the arrival of an inspector, all office administrators, personnel, or anyone who may open the door to an inspector must be trained in what to do upon their arrival. 

3. Project Manager.

It’s good practice to assign a Project Manager (PM) to the inspection readiness team as someone who can gather a list of all open items and tasks that need to be completed in order to become inspection ready. These tasks will come from various sources, such as gap assessments, prior agency inspections, internal inspections, and Corrective Actions identified through the QMS. 

The PM will prioritize these tasks and create a timeline to ensure all Quality Improvement and remediation actions previously identified have been properly addressed and closed out before the expected arrival of any inspectors. They will manage the status of open actions and update with additional actions as identified to maintain a constant state of readiness. The PM will also maintain the list of SMEs in each of the areas that may be inspected, as well as who will be filling the inspection logistics roles. 

4. Regulatory Affairs.

It’s important to have representatives from Regulatory Affairs to support the inspection readiness activities. They will most likely be in communication with your FDA colleagues about any related information requests and will also have access to all regulatory submission and approval data. The Regulatory Affairs representatives will also serve as your SMEs during the inspections to address any questions related to regulatory requirements.  

5. Scientists and Technical Experts.

There are many scientists and technical experts who will also be needed to act as SMEs during an inspection. These are the crucial participants who will be answering specific inspection questions about the key subject areas of the inspection. The SMEs are usually drawn from QA and related departments such as Manufacturing, CMC, Quality Control, Material Management, Clinical Operations, and Development.

SMEs provide support for the Back Room during the inspection by identifying, obtaining, and reviewing requested documents. SMEs may also be called into the Front Room to speak with the inspector directly. They must be familiar with your Standard Operating Procedures (SOPs) and ways of doing business. This entails knowing the content, and purpose of SOPs, as well as being able to explain how and when to use them. They should perform well under pressure and be able to easily answer questions concisely, confidently, and intelligently in front of the inspectors. 

6. Inspection Logistics Roles.

In addition to the SMEs, the inspection readiness team must identify and train people to fill several important inspection logistics roles during the actual inspection. This means it’s important to have representatives from your Information Technology (IT) department and company administrative support team who can serve supporting roles on your inspection readiness team. The IT team is responsible for verifying all network access and sharing portal needs are identified in advance, so these items are ready to be quickly set up at the time an inspection begins and so that the IT team can be available for support in case technology help is needed during the inspection itself.

The company administrative support team will also need to know which rooms will be used during the inspection so they can reserve them for the expected duration of the inspection and move any previously scheduled meetings. This team will also be responsible for sending out company-wide notification emails and instructions to make the company aware that an inspector has arrived on site. The inspection readiness team will often draft those emails in advance and hold them, so they are ready to be sent as needed.  

Inspection Readiness Team Roles and Responsibilities

Additional key inspection logistics roles include those in the Front Room directly interacting with the inspector and those who will be in the Back Room supporting the inspection behind the scenes. People will need to be identified in advance and trained for the following support roles:  

• Scribes: Documents the inspection process by taking notes on topics discussed, SMEs interviewed, and any other activities happening in the room. 
• Front Room Coordinator: Documents all inspector requests for documents or interviews and communicates them to the Back Room. 
• Back Room Coordinator: Responsible for prioritizing incoming inspector requests, communicating with SMEs to get requests filled, maintaining the status of requests, and communicating with the Front Room.

Once you have your inspection readiness team in place, and they’ve implemented the ongoing readiness plan, you can rest easy knowing you’re prepared to face the inspectors at any time. At Clarkston Consulting, we have experienced inspection readiness experts who can help with every step of this process. For a deeper dive into preparing for an inspection, reach out to us today.