What do you do when FDA inspectors visit your histopathology laboratory? Though it’s a routine visit to check your lab’s compliance with the accepted regulations, but it gives you a PANIC, isn’t it?
However, you can avoid being panicky by following these do’s and don’ts when FDA inspectors pay a visit to your lab.
- Ensure that all the facilities and staff at your lab follow GLPs and company SOPs strictly. SOPs or Standard Operating Procedures are the written guidelines for an individual or a group to perform the task without any variation.
- Create a culture of GLP knowledge, understanding, and compliance in your histopathology lab.
- Review the GLP questions and answers document. The document consolidates all GLP questions that have been answered by the agency in past 2 years and clarifies your specific doubts.
- Ask your Quality Assurance Unit to review all SOPs and audit the lab facilities annually. This will help to avoid any failures in following the protocol, missing files or information, substandard record-keeping, and poor maintenance of equipment’s.
- Tell a lie to the FDA inspector or ask your employee to do so.
FDA visit to your histopathology lab need not be a source of frustration for you. Be calm, positive, and confident. With these do’s and dont’s, your lab will get a clean FDA audit.
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