Members of the Quality Leaders Forums (QLF) for Life Sciences met in Princeton, New Jersey to discuss the ins and outs of audit preparedness in the midst of an ever-changing regulatory environment. Ed Morris, President and CEO of The Morris Group, shared his expertise with the group, suggesting that the first step should be to thoroughly evaluate your organization’s Quality Management System (QMS) and identify any gaps.
Additionally, attendees contributed their own experiences and expertise to the dialogue. Here are some key tips that were shared by the quality and compliance experts at the Princeton-area QLF:
How to get started
Perform a risk assessment, prioritize according to risk, understand that there's bias in estimating risk-so select a cross section of people for this, be upfront with the auditing agency by documenting this approach. Also prepare your staff for the possibility of live questions in the facility during walk-throughs.
-Londa Ritchey, LRitchey GMP Services
Developing a culture of quality
Audit preparedness needs to be a consistent and continuous effort. Do not wait until an audit is coming up. And more importantly, don’t allow your team to get complacent just because they passed an audit without any ‘major’ findings, especially when you know that there are deeper issues lurking. Management support for continuous improvement based on an honest assessment of your quality profile is critical.
-Sourav (Neil) Banerjee, QMS Integrity
When you identify gaps in your audit preparedness, how do you manage?
Take a risk-based approach to more easily set priorities and action plans, especially where resources are constrained. If procedures are a problem, remember to focus on developing procedures that are straightforward and easy to read. If these issues arise during the formal audit/inspection, acknowledge when you have shortcomings and be able to detail how you are working on improving for the future.
-Ed Morris, The Morris Group
Preparing the whole team for the audit
My company has a dedicated team for audit preparedness and we go through inspection behavior training so that everyone knows their specific roles and how to act during an audit. And setting up a “war room” nearby to stage/deliver documents or prep materials you know will be requested is very helpful.
-Natasha Madhow, Clinical Genomics
If you receive an observation
Observations are good - we learn from them and we shouldn't be afraid of observations. Quality system management should follow up with the observations and address the issues in a timely manner through investigations and a CAPA plan to prevent recurrences.
-Dr. Mahander Reddy Alluri, Globex MRA Consulting
Addressing gaps with an impending audit looming
Before the audit, draft an immediate action plan addressing the known risks identified while drafting regulatory/CMC content and the mock audit. Add any new gaps found during the audit, along with specific remediation and effectiveness check planning. You have the option to share parts of these plans (including timelines) with auditors to demonstrate that your Quality culture actively identifies and assesses risks, and that you embrace documented continuous improvement.
-Michael Spangler, Spangler Consulting
What else?
Thanks to everyone who attended the event for contributing to this important dialogue. In addition to all of the best practices above, the importance of communication and support from company leadership can not be stressed enough. Ensure that your leadership understands the criticality of audits and what is at stake. If you fail to get their buy-in, it is inevitable that the quality management system (QMS) will fall short due to insufficient resources and budget.
To learn more about the Life Sciences Quality Leaders Forum, click here>>