Internal reviews and subsequent corrective action plans are essential components of the Food and Drug Administration’s (FDA) Compliance Policy Guide (7150-09) in ensuring that fraud or otherwise subversive actions are identified and corrected to promote quality assurance. Such oversight is critical to ensure data reliability and agency integrity and to protect the public from potential harm.
To ensure that specific policies and procedures are followed, the agency recommends using outside consultants who are well-versed in all aspects of FDA activities, products, and processes with respect to submitted applications because of the complexity inherent in responding to FDA notice and questions.
Of particular importance is that even if an applicant conducts an internal review, the FDA will not rely solely on said review and will conduct its own audit and subsequent investigation. This underscores the necessity for any applicants to ensure that they follow all rules and recommendations fully. Among the most oft-cited reasons for utilizing an outside consultant is to lend credibility to any internal review.
The internal review
The fundamental purpose of an internal review is to “identify all instances of wrongful acts associated with applications” submitted to the FDA to include “any discrepancies between conditions identified in approved applications and manufacturing conditions during actual production.”
To fully adhere to FDA requirements, an internal review must include:
Analysis of the problems identified by the FDA
Specific and suitable audit plan
Audit data collected in accordance to the aforementioned plan
Audit reports that accurately reflect the findings
Components of the audit plan
A comprehensive and suitable audit plan must contain the actual scope of the audit in which information is validated via interviews with relevant personnel, examination of specimens, documentation review, and sample analysis to provide complete answers to any questions the FDA may have of an applicant.
The audit plan must also contain a comprehensive description of all controls to be used to ensure impartiality of the audit process. Here is where an outside consultant is especially important to lead the audit team. In that vein, the consultant’s qualifications—as well as all members of his/her team—should be included to demonstrate that s/he possesses adequate education, training, and experience crucial to conduct an appropriate audit.
Finally, the audit plan should contain a projected timetable for conducting and completing the audit as well as a scheme for describing, analyzing, and presenting the findings.
The corrective action plan
This plan puts forth all details of how an applicant plans to correct any unacceptable, improper and/or violative practices to prevent any future occurrences of potential wrongful acts.
Among the necessary components of the corrective action operating plan are:
Analysis of the audit findings
Disposition of any consultant recommendations
Description of actions taken to correct any wrongful acts, fraud, or deficiencies identified by the FDA
A timetable for implementing the corrective actions
Identification of personnel responsible to assuring completion of each step of the plan
Procedures to monitor the plan’s effectiveness
Points to consider for internal reviews and corrective action operating plans. (1991 June). U.S.
Department of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Enforcement, Division of Compliance Policy (HFC-230). Rockville, Maryland.