Why is Mandatory an Audit Program according to the FDA?

In this article, you will learn why is mandatory an audit program in compliance with cGMP Good Manufacturing Practices.

Government regulations require that regulated companies bring the audit to their quality systems with some frequency.

Some industries work under stricter audit requirements due to the type of process and product.

Failing to comply with the audit requirements, can cause fines, loss of business, or damage to a business’s reputation.

Moreover, the GMP and the QSR dictates why is mandatory to establish a reliable audit program.

In addition, the audit management system serves as a logbook and tracking system of all audit observations in the chronologic order that were done. It helps to bring the evidence that audit has been done to each area by date during its life cycle.

REGULATORY CONSEQUENCES TO NOT PERFORM AN ADEQUATE AUDIT ON-TIME?

Failure to adhere to a proper audit program and schedule is considered a violation of US Federal Regulations on good manufacturing practices.

As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to bring audit actions, and failed to design and implement an effective audit control program or management system either manual or electronic.

In some cases, it may result in an FDA warning observation, product hold, product recall, etc.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES: Why is mandatory an audit program

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS

PART 820 Medical Devices

820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.22

2 CFR § 200.501 – Audit requirements

httpss://www.law.cornell.edu/cfr/text/2/200.501

For more information about why is mandatory an audit program, refer to:

httpss://www.intertek.com/auditing/gmp/

httpss://haccpmentor.com/gmp/gmp-audit/

httpss://ispe.org/initiatives/regulatory-resources/gmp/audit-considerations

httpss://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

httpss://www.fda.gov/media/90179/download

httpss://www.orielstat.com/blog/what-is-mdsap-certification/

httpss://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/

httpss://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-single-audit-program-mdsap