Accredited Persons (AP) Inspection Program

by Nikita Angane | Apr 9, 2021 | Audits, Digital Health, Medical Devices, Pharma, Regulatory

The Accredited Persons (AP) Inspection Program allows for accredited persons to conduct the equivalent of an FDA quality system audit for manufacturers of FDA-regulated products. The accreditation is granted to third parties based on certain eligibility criteria and training. Manufacturers can opt for an accredited third party to inspect their facility when they meet the eligibility criteria.¹

In order to avoid conflict of interests and maintain the integrity of this program, there are certain eligibility requirements to be an accredited person to conduct FDA inspections. Some of them are: 1

Qualifications for AP personnel will be equivalent to that of FDA personnel.
FDA retains responsibility for making the final compliance decision of the inspection.
FDA conducts onsite visits periodically to each AP to audit performance and inspect records, correspondence, and other materials relating to the inspection under the AP program
FDA will monitor and evaluate each AP’s independence and compliance with the act.

FDA pays special attention to ensure that the parties seeking accreditation are free from any commercial or financial pressures to effectively carry out an impartial audit.¹

For manufacturers, the eligibility to be inspected by an accredited person is primarily based on the firm’s compliance history and whose most recent inspection by the FDA was classified as either “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”.¹

The AP program is similar to how the EU Commission relies on accredited third-party entities such as notified bodies to conduct competency assessments and regulatory duties. It would be interesting to see how this program flourishes in the future and companies respond to this process. So far, FDA has been using APs for the last 5 years and has completed about 90 FDA inspections through accredited third parties.¹

Need help with pre-inspection prep? Call us today at 248-987-4497 or email us at info@emmainternational.com to learn more about how we can help!

¹FDA (Aug 2020) Accredited Persons Inspection Program – Guidance retrieved on 03/30/2021 from https://www.fda.gov/media/73458/download

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.