Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices. Compliance auditing involves a systematic approach that evaluates whether a firm adheres to regulatory requirements, industry standards, and has appropriate internal policies and procedures.
The importance of compliance auditing cannot be overstated, it plays a vital role in protecting public health and safety. In this article, we will explore common Critical audit findings identified by Health Authorities and discuss the observations made by ProPharma’s GxP Compliance Auditors in the audits that we conduct.
There is no room for error, our industry is expected to provide safe & effective products 100% of the time.
As your auditing partner, we offer individual audits or support for your full Vendor Management program, both onsite and remote, with a collaborative, flexible, and dynamic approach. We ensure alignment with current and evolving industry trends, regulations, and standards for all GxP auditing compliance types throughout the regulatory lifecycle stages.
Our auditors have significant and direct experience conducting a full spectrum of audit and assessment types. They also provide crucial support during health authority inspections and assist companies in their pre-approval preparations.
ProPharma's audit coordination team serves a direct point of contact for our client’s, assisting in the facilitation and management of audit logistics, providing periodic progress status updates, maintaining audit timelines, and ensuring completion of deliverables between client’s and auditors.
ProPharma's Compliance Consultant subject matter experts support the Global Audit Program with compliance expertise, providing technical support for audit process and peer review of deliverables. Subject matter expert consultation with clients is also useful when serving as an extension of their clinical and commercial Quality teams, partnering in a constructive and collaborative manner, to evaluate internal and vendor systems for quality improvements.
Global Health Authorities face a challenging responsibility of monitoring and enforcing safety, efficacy, and quality of food, drugs, medical devices / diagnostics. One way they accomplish this oversight against regulations is by conducting inspections of regulated firms. During these inspections the Health Authorities identify various findings, or non-conformances that deviate from expected standards and regulatory requirements. These violations range from minor issues to serious "Critical" violations, potentially leading to enforcement actions, such as product recalls or even shutdowns of studies or facilities.
In our WHITEPAPER, we present an in-depth examination of the most frequently cited "Critical" violations by Health Authorities. Below, you'll find some of these violations that we delve into extensively.
As Global GxP Auditing is one of our core service offerings, we complied and analyzed our "Critical" audit finding data from our last 1,000 audits.
|
Severity Category |
Frequency / Audit |
|
Critical |
5% |
|
Major |
64% |
|
Minor |
159% |
|
Recommendation |
97% |
Download the Common Audit Findings Whitepaper to learn about the Critical findings we've identified how they compare to what Global Health Authorities cite.
Mindfully considering common issues identified by health authority during industry inspections can prove productive in evaluating your own systems. It enables you to watch for similar problems and ensure the robustness and optimal functioning of your Quality Management System.
ProPharma is the first-ever Research & Consulting Organization (RCO)—a leader in strategy, offering customizable design, and delivering consulting solutions equipped to navigate the ever-evolving regulatory environment successfully. Our proven worldwide expertise across the full lifecycle, including Regulatory Sciences, Clinical Research Solutions, Quality & Compliance, Pharmacovigilance Solutions, Medical Information, and R&D Technology services makes us your preferred single-source partner.
Contact us to explore potential partnership opportunities and discuss how we can assist you. Let us know "when, what, and how" you would like to schedule your audit!