“Prepare for an FDA inspection with these expert tips and best practices. Learn how to stay compliant and avoid penalties by preparing your facility and staff.”
FDA inspection preparation could be a nightmarish task but needful to meet and avoid regulatory penalties or sanctions. In this perspective piece, we will add some tips for preparing for an FDA inspection that could help you succeed.
Know the Reason for the Inspection
Understanding the goal of an FDA inspection is the first step in preparing for it. The Federal Drug Administration (FDA) carries out inspections of regulated companies to ensure compliance with FDA regulations and guidelines. Familiarity with the FDA priorities will help you to be prepared.
Conduct a Self-Audit
Prior to an FDA inspection, it is best practice that you perform some form of self-audit of your facility and operations. It will help you find compliance problems and solve them before the FDA comes. Consult all relevant and applicable FDA regulation/guideline(s) and evaluate your practices.
Train Your Staff
During an FDA inspection, your employees are the frontline. Adequate training for the staff about FDA regulations, policies and procedures is vital. Hold some training sessions to prepare them for what they will be like when an FDA inspection takes place.
Maintain Records in Sequential Order
Documentation of how your activities are conducted is one of the most important components that will be observed during an FDA inspection. Maintain detailed, accurate records of all procedures such as manufacturing; packaging and labelling to prove that you are complying with the guidelines required by the FDA. Make sure that all records are collected and can be accessed without trouble
Have a Plan in Place
It is just as important to have a plan in place prior to the inspection by agencies such as the FDA for smooth passage. Describe the personnel who will participate in the inspection, including their roles and responsibilities. Create a list of things that will be inspected and make sure you prepare all areas accordingly.
Get Ready to Be Asked Questions
During an FDA Inspection there are countless questions that the inspector will have regarding your facility, operations, and products. Questions like these need professionally trained and informed personnel who can field them confidently and accurately. Make sure that everyone interacting with the FDA during the course of an inspection knows how to answer questions.
What to Do After the Inspection Results Are In?
The FDA will issue a report summarizing the observations/findings from the inspection. Follow up on these findings in a timely manner and do remedial as appropriate. This shows to the FDA that you are serious about compliance and maintaining standards with regulatory requirements.
Conclusion
Hopefully, you learned a few ways to prepare for an FDA inspection, which can be tough, but is so important to comply with and avoid fines or some penalties. Preparing for an FDA Inspection — The Definitive Guide by understanding the purpose of the inspection, practicing a self-audit, training your employees, keeping proper records, being planful with communication during the inspection (most importantly having a plan in place), preparing yourself to answer questions and appropriately following up on findings derived from the inspection is key to being successful.
Reach out to BioBoston Consulting today or check our website for more on how we can help your business.
