Is your biotech company ready for an FDA inspection? This guide outlines the must-know items on the FDA checklist and shares tips to strengthen your innovation strategy.
Maximize your chances of a positive outcome.
An FDA inspection aims to confirm an organization’s adherence to the laws and regulations of the FDA, from Good Manufacturing Practices (GMP) all the way down to Quality System Regulations (QSR).
But the threat of an FDA inspection does not have to scare you because preparation precedes victory. Here is your comprehensive checklist for FDA inspection, walking you step by step on what you should do not merely to survive but to flourish in an FDA inspection.
Understanding the FDA Inspection Process
It is worth understanding what an FDA inspection really is. The FDA inspects mainly to check compliance with FDA regulations on whether products are safe, effective, and of high quality.
Inspection Objectives:
The main purpose of an FDA inspection is to determine compliance.
Violations Detection: The FDA investigator will try to detect a violation of FDA requirements. Violations will be brought to regulatory action such as the issuance of warning letters, recall of the product, or filing a case in court.
Public Health Security: The bottom line of FDA inspections is public health security. It will ensure that all the quality and safety standards are met for marketed products.
FDA Inspection Checklist: Preparation for Success
I1. Selection of Audit Team: Form an audit support team with defined roles and responsibilities. Appoint a PR person for the FDA auditor.
2. Document Control: Maintain on record all relevant documents including Standard Operating Procedures (SOP’s), batch records, and quality control reports.
3. Site Ready: Ensure that your facility is clean, organized, and kept extremely clean; verify that all equipment is functioning properly.
4. Training and Education: Educate employees on FDA regulations, procedures for inspection, and role when the FDA investigator calls to inspect. Also, conducting a mock inspection can be very beneficial, simulating a real FDA inspection could prepare the facility and personnel for the real one.
5. Communication Plan: Prepare a communication plan so that all the employees are to be educated on how they should respond to inquiries from the FDA inspector. Make them aware that they may answer questions to the best of their ability but briefly.
6. Action to Observations: Ensure that a plan is developed and implemented to meet any observations or violations presented from the inspection. Develop corrective and preventive actions when necessary.
7. Access to Records: Ensure that all records the FDA inspector requests are accessible to view. Use validated electronic record management tools and grant access accordingly.
8. Adverse Event Report: If this is relevant, have a documented process for how adverse events or product complaints will be reported to the FDA.
9. Supplier Audit: Schedule audits with your critical suppliers to validate compliance with applicable FDA requirements. Maintain records of all supplier audits and comments received for each requirement raised.
10. Continuous Improvement: Continuously strive for quality and improvement within your organization. Review and improve your quality management systems frequently.
Tips to have a Successful FDA Inspection
1. Keep Calm and Professional:
During the entire process of inspection, the personnel should be calm and professional.
Do not argue or dispute with the FDA inspectors; instead, you should provide proper information.
Better to be clear than to spread false information.
4. Note Observations:
Keep a note of the officer’s observations and any deficiency found.
All the issues identified in the inspection process will have to be addressed and corrected without delay.
4. Cooperate and be Open:
The FDA inspector should be provided with all the requested information.
Honesty and transparency breed trust.
5. Learn from It
An FDA inspection should be considered a learning experience, , highlighting areas where your approach or methods may need improvement.
Leverage the learnings to strengthen your organization’s compliance.
Conclusion
When you have an FDA inspection, it may be quite a daunting process, but by making the right preparation and commitment to compliance, it also presents a basis for growth and improvement. With this comprehensive checklist of inspection by the FDA and advice provided, your organization can walk through the entire process of inspection confidently, emerging from it stronger and more compliant than ever before.
At BioBoston Consulting, we serve organizations in the life sciences space to prepare for FDA inspections and maintain a culture of compliance.
Contact BioBoston Consulting today or visit our website to learn how we can help your organization.
