Preparing for FDA Inspections in a Changing Regulatory Environment - Pharmaceutical Technology

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Preparing for FDA Inspections in a Changing Regulatory Environment
Industry and regulatory experts provide advice on inspection preparation and best practices.


Pharmaceutical Technology


It is also important to be able to explain each employee's responsibilities and how the operations are managed. According to Rogers, "The compliance program serves as a recipe for our inspectional process, but for a PAI and especially for an initial inspection, we go through a complete history of the firm's operations, management, management structure, and responsibilities to get an idea of the firm's general operations as well as an understanding of the products they make." During a company's first inspection, adds Rogers, the team should be prepared to talk about the other products the company manufactures beyond the one under review.

Implement a remediation plan

After the mock inspection, companies should "seize the opportunity to enhance all the critical compliance categories that have been identified as deficient by your mock FDA inspection team and address them," says Medina.

For a PAI, one best practice is to eliminate any disparities that might have arisen since the time the submission was made and the time the PAI is to occur. "Information about the facility, manufacturing processes, QC methods, batch record, corresponding equipment, and anything substantive reported in the submission must be consistent with what the investigator will find and inspect against during the PAI," adds Medina. "The biggest reason for failure is the disparity identified by the investigator between what was reported in the regulatory submission's CMC [chemistry, manufacturing, and controls] section and what is actually found on the manufacturing floor and within laboratories."

Applying these strategies should go a long way toward a successful inspection process. "Overall, be forthright in making the appropriate people and records available to support your data," says FDA's Michael Rogers. "We're just trying to do our job. We have a role in public health to protect people, and so does the industry."

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