As a regulator, the US Food and Drug Administration (FDA) examines organizations involved in the manufacture of pharmaceuticals, biology, and medical equipment.
Many of these regulations enforced by the FDA affect clinical and laboratory facilities and employ best practices such as good laboratory practice, good clinical practice, human protection, and institutional review requirements.
You may search for FDA inspection 483 via https://wizmed.com/fda-inspections.
FDA investigations are carried out in the same process, whether you inspect a large manufacturing facility or a small laboratory. For small facilities, FDA inspections are often a challenge when the quality team lacks experience and resources.
1. Implementation of a fictitious internal audit
Although a fake exam may not fully prepare you for the actual exam, it will help you identify flaws in the procedure and put you in a better position to review compliance with FDA regulations. With fictitious audits, we can also learn from mistakes, anticipate questions that might be asked and train the key people who were directly involved in the actual audit.
2. Analyze risks and take necessary action in case of non-compliance
Because FDA investigators thoroughly review each process, conducting an internal audit can help you identify potential risks in your process and take any necessary corrective, preventive, or corrective action to resolve any inconsistencies that arise during the internal audit.
3. Easy access to current quality guides
Effective documentation is at the heart of a successful FDA investigation. Inspectors always ask for a manual with procedures that need to be reviewed for each department. Therefore, it is important to have the most current and complete quality manual for all facilities.