FDA Draft Guidance - Medical Device ISO - Voluntary Audit Report Submission Program

The Federal Register notice just announced the availability of the FDA Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.

The medical device ISO 13485:2003 Voluntary Audit Report Submission Program outlined in this draft guidance is another way in which FDA may leverage audits performed by other Global Harmonization Task Force (GHTF) regulators and accredited third parties in order to assist the agency in setting risk-based inspectional priorities.

The FDA recommends that a domestic or foreign device manufacturer that is subject to the requirements in 21 CFR Part 820, Quality System (QS) regulation be eligible to participate in the ISO 13485:2003 Voluntary Audit Report Submission Program under certain circumstances described on the FDA webpage (link provided above).

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FDA Final Guidance On ICH Q10 - Quality Control System

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If you follow quality issues in the GMP regulated industry space, you'll want to get up to speed on ICH Q10. Here's what the FDA has to say about this new guidance, FDA - Q10 Pharmaceutical Quality System:

This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH "Q8 Pharmaceutical Development" and ICH "Q9 Quality Risk Management." ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.

In summary, the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system by building upon good manufacturing practices (GMP). 

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21 CFR Part 820 QSR Audit Checklist - Are you ready?

Updated June 3, 2020

The original post didn't age well.

You might also be interested in this 21 CFR 820 Audit Checklist found on SCRIBD:
https://www.scribd.com/doc/162185575/122763962-Audit-Checklist-9001-13485-21-cfr-820

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If you're not quite ready, or are in the process of putting together your own internal audit checklist, it's a good idea to get ideas from others. Get a feel for checklist content, organization, and layout. Look at this excerpted portion of a checklist from Jack Kanholm's book (ISO 13485 and FDA QSR Internal Audit Checklist): ISO 13485:2003 Internal Audit Checklist - Demo Download.

Related Posts:
Free 21 CFR Part 820 QSR Audit Checklist

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