In this episode of Let’s ComBinate, we dive into the fascinating world of audits—a cornerstone activity for ensuring quality, compliance, and continuous improvement across industries. Whether you’re managing combination products, medical devices, or pharmaceuticals, audits are critical for assessing systems objectively and identifying opportunities for growth.
As the year draws to a close, I reflect on my own tradition of reading Managing Oneself by Peter Drucker. This essay, deceptively simple in format, offers profound insights into self-improvement, values, and performance—concepts that align remarkably well with the purpose of audits.
What Makes Audits So Valuable?
Audits are systematic, independent, and documented processes for obtaining and evaluating evidence against predefined criteria. For industries like combination products, they ensure compliance with overlapping regulatory frameworks, such as 21 CFR Part 4, which integrates drug, device, and biologic CGMPs. These audits help organizations maintain harmony in their quality systems, bridging complex regulations like:
- ISO 13485: Quality management for medical devices.
- ICH Q10:Guidance for Industry Q10 Pharmaceutical Quality System
- 21 CFR 820: Quality system regulation for devices.
- 21 CFR 210/211: CGMPs for drugs.
By ensuring compliance with these regulations/standards, audits provide a clear-eyed view of processes and help organizations uphold patient safety and trust.
Types of Audits in the Quality Landscape
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First-Party Audits (Internal Audits):
These are proactive evaluations within an organization to ensure the quality management system (QMS) is functioning effectively. For example, under ISO 13485, internal audits act as in-house checkups to catch and resolve issues early. -
Second-Party Audits (Supplier or Contractor Audits):
External evaluations of partners like contract manufacturers or test labs. This is especially crucial in the combination product space, where gaps in supplier compliance can lead to regulatory scrutiny. -
Third-Party Audits (Certification or Regulatory Audits):
Conducted by independent bodies or regulatory agencies like the FDA, EMA, or MHRA, these high-stakes audits can result in certifications or findings like Form 483 observations.
Each type serves a unique purpose, from internal preparation to external validation.
Audits vs. Inspections
While audits and inspections are related, they differ in focus and execution.
- Audits evaluate systems and processes holistically, ensuring alignment with standards like ISO 13485 or 19011.
- Inspections, often unannounced, target specific regulatory requirements to ensure compliance.
Think of audits as annual reviews and inspections as spot checks—both essential for maintaining quality and compliance.
Combination Products and Regulatory Complexity
For combination products, audits must address the unique integration of drug, device, and biologic regulations. The FDA’s guidance on combination product inspections emphasizes the need for robust systems that harmonize requirements from different CGMP frameworks. This complexity highlights the importance of a well-structured audit program to ensure regulatory readiness and product integrity.
Self-Audits and Personal Growth
Interestingly, the principles of audits extend beyond organizations. In Managing Oneself, Drucker emphasizes self-reflection as a tool for improvement. Questions like What are my strengths? How do I learn? What are my values? mirror the audit process of assessing and improving systems.
Just as audits help companies thrive, self-audits foster personal growth. As Drucker says, “Acting on this knowledge is the key to performance.”
Key Takeaways for Quality Professionals
- Audits are not about catching mistakes; they’re about ensuring systems work as intended.
- Preparation is key, whether for internal reviews or third-party audits.
- Transparency and constructive response to findings build trust and drive improvement.
- For combination products, audits bridge complex regulatory landscapes, ensuring compliance and patient safety.
Audits may feel daunting, but they’re among the most effective tools for growth, both professionally and personally. As we wrap up the year, I encourage you to reflect, audit yourself, and embrace the opportunity to improve—whether through Managing Oneself or your next QMS review.
Happy New Year, and remember: Together, we can simplify by combinating!
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