In the clinical research industry, approvals for investigational products are not granted- they are earned. Increasing numbers of FDA early-intervention and routine inspections can increase the stress levels of everyone involved in clinical trials. Auditing can be looked at as a quality assurance process, and a way to prepare for inspections and approval by:
- Identifying and addressing issues before the FDA finds them.
- Preparing for Inspections by reviewing the BIMO checklists and knowing what to expect.
- Proactively addressing compliance concerns through BIMO preparation audits.
- Verifying that vendors are qualified to do their jobs.
- Preparing the research team with mock inspections along with interviewing and coaching sessions.
Back in 2012 FDA released a Guidance for Industry concerning auditing titled, “Voluntary Audit Report Submission Pilot Program.” The program was intended for device manufacturers previously audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members (European Union, United States, Canada, Australia and Japan). These manufacturers voluntarily submitted resulting audit reports to the FDA for analysis. The FDA then used the audit results as part of its risk assessment to determine whether that manufacturer could be removed from FDA’s routine inspection work plan for one year.
In December of 2015, FDA announced the termination of the Voluntary Audit Report Submission Pilot Program and the start of FDA participation in the Medical Device Single Audit Program (MDSAP). This new program will launch on January 1, 2017 and will allows MDSAP accredited third parties to submit audit reports for use in FDA routine inspections. The MDSAP model may be a better fit for FDA as it encompasses legislation from the Code of Federal Regulations while the previous pilot program was built on ISO 13485:2003.The FDA is hoping to develop a more stream-lined routine inspection process in order to save time, resources, and money for all teams involved.
Auditing can help identify, analyze and strengthen weakness to ensure compliance, protect patients, and guard data integrity. IMARC offers auditing services, including:
- Site GCP Audits
- Sponsor/CRO Audits
- Vendor Qualification Audits
- BIMO Preparation Visits
- Mock Inspections
- IRB Audits
What do you think about the new MDSAP program? Do you think this will benefit the FDA and device manufacturers? Let us know your thoughts!Self Portrait (Magnify) via photopin (license)