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FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter. This means compliance at its highest and lowest levels.

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To simplify matters to an extent, the FDA has tried to be of some assistance to help in monitoring the conduct of all aspects of the conduct and reporting of organizations involved in FDA-regulated research. This has concretized in the form of the FDA’s Bioresearch Monitoring Program, or BIMO. This on-site inspection and data audit program can be used as a reference guide by industries in FDA-regulated research industries. Adherence to it is a yardstick for compliance with FDA regulations in the field.

In other words,compliance to the implementation requirements of the BIMO is a fair indicator of how well the organization comes out unscathed out of an FDA inspection. Meant for monitoring Clinical Investigators (CIs), the Institutional Review Boards (IRBs), Sponsors or Contract Research Organizations (CROs)/Monitors, and nonclinical laboratories; the BIMO spans quite a range of players in the FDA-regulated research.

What are the BIMO’s objectives?

The FDA’s Bioresearch Monitoring Program has two important objectives:

  • Protecting the welfare, rights and safety of human research subjects
  • Ensuring that the data collected by researchers is reliable and is of acceptable integrity and quality

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What are the BIMO’s functions?

The FDA’s Bioresearch Monitoring Program has a few functions, which research organizations that have to survive an FDA inspection could do well to comprehend. These include:

  • Clinical data auditing
  • Inspection of the ongoing clinical research
  • Subjecting nonclinical laboratories and IRBs to inspections
  • Taking steps to train, educate and implement the FDA’s Application Integrity Policy.

Understand the underlying causes that lead to an inspection

The key to passing an FDA inspection is to understand that there are strong reaons for which an FDA inspection happens. Research organizations that want to pass an FDA inspection have to get a grasp of the factors that prompt the FDA to inspect research. These include:

  • Introduction of a new technology
  • Introduction of a new product or an indication
  • Receipts of complaints by the FDA from aggrieved parties
  • CRO being a habitual non-complier

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