Life science quality audit and inspection frequency, volume, and modalities have been significantly altered by the COVID-19 pandemic, and there is evidence that some changes are here to stay.
Quality audits are essential for life science manufacturers to assess their quality management system (QMS) and processes for compliance with industry guidelines and regulations. They also provide the opportunity for quality management teams to proactively address any gaps or limitations in their efforts to ensure product quality and safety.
Leveraging internal resources for external audit success
In its Resiliency Roadmap for FDA Inspectional Oversight report, the U.S. Food and Drug Administration (FDA) outlines its plans to address the drug and device manufacturing inspection backlog caused by the pandemic, and includes the continued use of remote inspections and requests for manufacturers to share records remotely to “support on-time regulatory decision actions.”1
In the first blog of this series, we outlined steps that a life science manufacturer should take to conduct an efficient but comprehensive internal audit of its quality operations. In this post, we explain how a manufacturer can leverage the fundamentals of internal audit planning for external audit success.
Create a culture of quality
When preparing for an audit, it’s important to remember that quality isn’t a standalone entity, rather it is an attribute that impacts and is impacted by virtually every aspect of a life science manufacturer’s operations. Expect auditors to examine quality processes across the board and in each department or function.
To keep quality as a focus among all stakeholders and identify quality lapses in real-time, life science manufacturers are employing cloud-based electronic quality management systems (eQMS) that integrate all core quality processes and data within a single system. This includes document management, training management, change control, deviation/CAPA, customer complaint, risk management, audit management and supplier quality.
When everyone stays on the path to quality improvement – including external suppliers – a manufacturer has confidence that audit requirements will be met and compliance confirmed.
Prepare data and documentation for auditor inquiries
The demands of an audit don’t need to come as a surprise to a life science manufacturer, nor should they completely disrupt operations. With a fully validated, cloud-based eQMS featuring automated audit management capabilities based on life science industry best practices (e.g., FDA, ISO, GxP) a manufacturer can be prepared at any time for an evaluation of its quality management operations.
In its January 31, 2022, report, FDA Inspection Readiness for Medical Device and Drug Manufacturers During the Pandemic, legal consulting firm Faegre Drinker notes how FDA inspections of pharma and medical device firms in 2021 cited “many facilities for noncompliance with fundamental current good manufacturing practice (cGMP).” The author states:
“Conducting mock inspections and quality control (QC) audits that focus on these core cGMP principles prior to the next inspection could help sites avoid FDA’s most cited observations.”2
Having all data and documentation in the eQMS, a quality team can run the full range of scenarios – from a complete picture of quality processes and controls, down to specific details (e.g., batch records) – all from a single solution when conducting a mock QC audit.
Be proactive not reactive to remote audits
With the pandemic limiting travel, the FDA has conducted more than 600 remote regulatory assessments in the U.S. and more than 200 remote assessments abroad to carry out “critical oversight” of the life sciences industry.3
If remote inspections continue to grow, life science manufacturers that still rely on manual, paper-based quality management processes will find it challenging to comply with auditor requests for electronic documentation during an audit.
As one auditor stated, “During the course of a few audits I have conducted since early April 2020, I have had personnel literally hold a piece of paper up to the video for my review.”4
Transitioning now to a With a fully validated, cloud-based eQMS featuring automated audit management capabilities based on life science industry best practices (e.g., FDA, ISO, GxP) a manufacturer can be prepared at any time for an evaluation of its quality management operations.
References
1 Next Steps: The Road Ahead for the COVID-19 Response, FDA, November 4, 2021
2 FDA Inspection Readiness for Medical Device and Drug Manufacturers During the Pandemic, Faegre Drinker, January 31, 2022
3 FDA, working to tackle pandemic inspection backlog, struggles with foreign oversight and site visits for new drugs, Fierce Pharma, November 23, 2021
4 Remote Auditing: An ISO 9001 Auditor’s Perspective, The Auditor, December 20, 2020
Catch up with part 1 of the series – Steps for a Successful Life Sciences Quality Audit – Part 1
