Successful regulatory inspection outcomes require preparation and communication. While inspections are challenging, having the process run smoothly is achievable with proper preparation. Inspection readiness is about continuous improvement and ensuring the team is ready to navigate the complexities of a regulatory audit with confidence.
Not being ready to meet the regulator’s requirements during the inspection process is a huge risk, since an unsuccessful inspection will add significant time to a company’s strategic goals.
To successfully prepare for an inspection, organizations should consider adopting best practices. This article explores eight invaluable tools for inspection success.
1. Be properly prepared
First impressions matter, so it’s vital that the areas the inspectors are going to see are clean, tidy and well organized. If your areas are well presented, this will give the inspector confidence in the site, since having a well-maintained and well-presented site implies good overall processes.
Consider the implementation of a 5S program in your area1 . As a system for organizing spaces, 5S helps to establish an orderly work environment in addition to improving efficiency. Achieving inspection readiness should not be a snapshot in time but an ongoing commitment to maintaining day-to-day standards at the site. Some helpful tips on how to implement a 5S program can be found here2.
Another good preparatory step is to prepare a folder of documents that could be requested in advance. This way the documents will be quickly to hand should an inspector request them. For larger documents, compile a categorized list, including location, so you can easily find them. Make sure that you, or the identified subject matter expert (SME), are familiar with the documents and are prepared for any potential queries. For onsite as well as virtual audits, it is recommended to have a ‘War Room’ in place where these prepared documents can be left and checked for accuracy and completeness before being shared with an inspector.
2. Do What You Say You Do
This is a common pitfall during inspections. Many observations have been assigned to sites for lack of procedural accuracy. Always be clear and concise in your standard operating procedures to ensure consistent execution of routine operations. Ensure that the overall requirements of your procedures describe the exact steps for the successful execution of the procedural activities. However, it is essential to have the appropriate balance in your level of detail. Do not be tempted to add too much granularity and get into minute detail since procedural detail opens you up to non-compliance when the inspector reviews the process.
Be sure to conduct periodic reviews of your procedures. To keep procedures accurate, efficient, and effective in terms of their intended use, it is important during this process to involve the people who use those procedures on a regular basis. They can provide valuable hands-on experience and insight resulting in robust procedures.
3. Know the Process and be prepared
It is important to understand the necessary regulatory inspection process and it is indeed an expectation from the inspectors that sites have this understanding. The FDA website contains some useful guides which can be referred to, such as What should I expect during an inspection?3. The website also contains a set of Inspection Guides4 which are useful in preparation for inspections as they contain reference material that the inspectors will use during the inspection. these regulatory guides will provide information as to what the inspectors will be looking for, specific to that inspection area.
During and after the inspection, the inspectors may have a list of observations for the site. Review these with the inspector as they arise and attempt to remediate them immediately, where feasible. This will show the inspector that the site is committed to achieving and maintaining a compliant state and will help to promote and build a positive relationship with the regulatory agency. Fostering a good relationship with inspection agencies is important as it shows the agency that the site is supportive of the process, which will benefit you in future inspections.
Sites should strive to be audit-ready at all times. This approach not only promotes a constant state of control and continuous compliance, but saves energy and resources in the long run.
4. Practice makes Perfect
An effective self-inspection program is vital in preparing the site for inspection success. These are a great opportunity to ensure your area is compliant in advance of inspections and remediate areas of concern. Discuss the self-inspection in advance with a dedicated team and request a review of any areas of concern within your department. Whilst this may be challenging, it is preferable to identify potential deficiencies and resolve them rather than to have them identified by an inspector as an observation.
Self-inspections are a great training opportunity where you can practice and develop your inspection approach. Use this time to role play, polish your inspection skillset and train inexperienced personnel. Using an independent party is an option to consider, for example, GMP consultants. The benefit is that these would not have prior knowledge of your company and are unbiased.
The internal audit schedule needs to be at an appropriate frequency to be effective. Senior management should empower the self-inspection team with the required level of authority to hold functional areas accountable and ensure that they push actions through to completion.
The internal audit program should also be assessed to ensure that the self-inspections are not only performed on independent functional areas, but also laterally across departments, using a system-based approach so that all the interconnected elements between processes are audited.
5. Become Comfortable with the Uncomfortable
Each team should review their list of investigations/discrepancies for their area, identifying those they anticipate the inspector may request to review, or the ones believed to be an area of concern. The person who is likely to discuss the issue with the inspector should be well versed in all aspects of the investigation, fully prepared and confident to present on the topic and answer questions they may face.
Have all required supporting documentation readily available. Consider putting together a presentation to ‘tell the story’. This can provide clear context to the event should the inspector take a deep dive into it and allows the presenter to use it as a guide to stay on track during presentation to the inspector. This strategy can be applied to any area of concern. Try to identify other areas that review of an investigation or similar document may lead to, and have documented information and, if required, a documented position or strategy to prevent risk to the product.
6. Prepare your Team
Area SMEs should be identified in advance of the inspection. Ensure that they are confident in their ability to engage with the inspectors and are well prepared to discuss any areas of concern that may be identified.
Personnel should be appropriately equipped with the tools to interact with the inspector. Inspection skills and behaviors should be part of an internal training program, with appropriate retraining. Ensure that personnel are fully trained on the procedures required to complete their tasks and that training records are up to date, reviewed and readily available during the inspection.
As part of this training, try to include role play workshops, where personnel present on their area of specialty, as they would in a real inspection situation. This can really help to build confidence and result in stronger and more confident responses to the inspector’s queries. Conducting a mock inspection is a good opportunity to determine whether the inspection process runs smoothly, allowing for final adjustments where necessary.
Promoting the correct mindset in this area is also very important. Inspectors are there to ensure that the products being supplied are safe and effective for the patient. Recognizing that this is a necessary and positive process will help your team to understand why preparation is so important.
Equally, it’s important to support your team. In a hectic inspection, it is often easy to forget that not everyone is experienced in the inspection process. Some team members may be new to the industry and unfamiliar with inspections. Be mindful of this and offer support or advice where necessary. Also, be cognizant of your colleagues in other departments. If support is needed and can be provided, do so. Remember, a successful inspection is a team effort and site-wide goal, not just for the area that you are working in.
7. On the Front Line
When speaking with the inspectors, there are a few golden rules that need to be observed:
- Be prompt with a documentation request. Should the inspector request a document, provide it as quickly as possible. If it is not available, do not evade their request, admit this up front.
- Admit to, rather than hide, known deficiencies. Where possible, the plan for remediation should be prepared during inspection readiness and be readily available. It is better to show you have identified issues and have a plan in place to remediate them, rather than hoping an inspector does not find an issue, which can give the impression the site was unaware.
- Provide only the information directly related to answering the inspector’s question, do not offer any additional information.
- If you do not know the answer to a question, say so. Tell the inspector that you will find the answer and come back to them as soon as possible.
- Do not use language like, ‘Sometimes’, ‘Occasionally’, ‘To be Honest’, ‘In my Opinion’.
- Maintain a very high level of professionalism. Questions should be directed at the inspector in a polite and professional manner.
Inspectors can vary widely in terms of their inspection style or approach. If you are finding the interaction with the inspector challenging, remember the tips above.
8. Do your Homework
It is advisable, in advance of any upcoming inspections, that you perform some reconnaissance. Complete a review of publications and articles and see what the current trends are in terms of what areas or topics inspection agencies are frequently looking into during their inspections. For example, information on FDA observations given to sites, or 483s, can be found on the agency’s publicly available website and can be reviewed according to the industry area and fiscal year. These findings should be communicated across the team so that all are aware of the current trends.
If you happen to have a network of sites within your company, it is in your mutual interest to maintain lines of communication and share your inspection experiences to aid in and support each other’s preparation. Often, when an inspector discovers a discrepancy at one site, they will look for the same at another site in the network.
About the author:
Louise Uí Fhatharta is a consultant/manager at PharmaLex, and has more than 20 years of experience as a quality professional in microbiology, quality control and quality assurance roles in the pharmaceutical industry, including sterile fill finish and medical devices. She has experience in leading FDA, Ireland’s HPRA and Germany’s DEKRA Health Authority inspections.
- What is 5S? Training for 5S Lean Methodology, Systems & Principles, Creative Safety Supply. https://www.creativesafetysupply.com/content/education-research/5S/index.html
- Who should implement 5S, Creative Safety Supply. https://www.creativesafetysupply.com/qa/5s/who-should-implement-5s
- What should I expect during an inspection? FDA, https://www.fda.gov/industry/fda-basics-industry/what-should-i-expect-during-inspection
- Inspection Observations, FDA. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations
