FDA Will Focus on Audit Reports During Inspections

The FDA is focusing on auditing. For example, it is considering how drug ingredient supply chains need to be audited, according to Steve Wolfgang, a consumer safety officer with the Division of Manufacturing and Product Quality in the FDA Center for Drug Evaluation and Research’s Office of Compliance.

He emphasized the importance of drugmakers’ audits of ingredient suppliers to ensure there are no unknown good manufacturing practice (GMP) deficiencies. He also encouraged companies to pay attention to suppliers’ GMP and good distribution practices.

For devices, the agency is authorized by the Medical Device User Fee Act to take ISO audit reports into account when selecting which facilities to inspect. Manufacturers would voluntarily submit the reports.

“I’m going to be very positive about [ISO audit reports] in regards to who we are going to inspect and so direct our districts,” Timothy Ulatowski, director of the Center for Devices and Radiological Health’s Office of Compliance, said. The audit reports can be used by devicemakers “to indicate to FDA that [the company] had a satisfactory ISO audit. ‘FDA, go somewhere else. We’ve been seen by an auditor,'” Ulatowski said.

An effective audit program must streamline auditing and assessment processes, which will facilitate an organization’s ability to guarantee product quality and reduce its risk of noncompliance through:

• Improved planning — Enterprisewide implementation connects various departments and locations. Automation makes scheduling and performing audits faster and easier.
• Enhanced audit management — Audit teams, lead auditors and departmental identification can be defined and managed.
• Streamlined audit checklists — Consistency within audit data makes analyzing and comparing data easier, resulting in faster audit conclusions and related resolutions.
• Consistent use of audit reports — When audits are complete, the data is analyzed and used in a uniform report, eliminating incomplete and confusing reports.
• Identification of high-risk areas — Key performance indicators can be derived from global and local data trending. Root causes and appropriate corrections can be quickly identified.
• Increased global visibility — Use of a centralized database offers visibility into company performance. Consistent documentation and configurable reporting abilities increase insight into effectiveness and contribute to informed decisionmaking.
  

Accelerated and effective audit processes can assist an organization with monitoring product quality and compliance. Quick analyses of data, consistent documentation and the ability to categorize audit findings can help manufacturers to improve quality. The improved ability to organize audit programs reduces administrative overhead and production costs.

Enterprisewide, integrated audits provide manufacturers with a way to ensure standardization across the organization, maintain product quality standards, reduce the risk of noncompliance, prepare for third-party audits and reduce costs.

SOURCE: FDANEWS