Are you concerned a vendor’s restructuring might impact GLP compliance? Learn how third-party audits ensure data integrity and smooth drug development.
Vendor Audit Background and Challenges
Our client, a major international pharmaceutical company headquartered in Italy, had partnered with a third-party vendor for the provision of laboratory services.
The client’s vendor, a global life sciences and healthcare company, had undergone a structural reorganisation in recent years, which changed how services were delivered, documented, and trained.
The recent structural reorganisation raised concerns about their continued compliance with Good Laboratory Practice (GLP) regulations.
What is the potential impact on GLP compliance?
Significant structural changes within a laboratory service provider can disrupt established practices and documentation procedures. This can lead to several potential issues impacting GLP compliance:
- Inconsistent data collection and record-keeping: New workflows or staff roles could lead to inconsistencies in how data is collected, documented, and stored. This has the potential to compromise data integrity and traceability, both of which are crucial for GLP compliance.
- Inadequate training on revised procedures: If staff have not received adequate training on updated procedures following the reorganisation, they may be at risk of deviating from the procedures and, in the event of major deviations, there could be departures from GLP principles.
- Unclear lines of responsibility and accountability: Restructuring can blur ownership of tasks and responsibilities, making it difficult to ensure activities are conducted according to GLP guidelines.
These issues, if left unchecked, can have serious consequences, including:
- Data rejection by regulatory bodies: If an audit or inspection reveals deficiencies in GLP compliance, regulatory bodies may reject data submitted in support of drug applications. This can significantly delay product development and marketing.
- Reputational damage: Public disclosure of GLP non-compliance can damage a company’s reputation and erode public trust in the safety and efficacy of their products.
Our GLP Vendor Selection Approach
Arithmos deployed experienced GLP auditors to assess the vendor’s compliance status on behalf of the pharmaceutical client. Here’s how we ensured a smooth and successful audit:
- Collaborative planning: We liaised with both the client and vendor to schedule the audit at a mutually convenient time. A confidentiality agreement was established to ensure data security during the process.
- Comprehensive audit plan: We created a detailed agenda outlining the audit’s scope, including facility tours, staff interviews, and document reviews. This plan covered the new organisational structure, processes, quality control/assurance systems, and all aspects relevant to GLP compliance.
- Client involvement: We maintained continuous communication with the client throughout the audit. They participated in key meetings to ensure their concerns were addressed and queries relayed to the vendor staff.
Client’s Success Factors and Outcome
Following the audit, Arithmos delivered a comprehensive report with a classification of findings agreed upon with the client. The report concluded that, with appropriate corrective and preventive actions (CAPA) implemented, the vendor would be suitable for continued GLP-compliant service provision.
The key factors contributing to this success were:
- Experienced auditors: Our team’s deep understanding of GLP regulations ensured a thorough and rigorous assessment.
- Collaborative communication: Effective communication between Arithmos, the client, and the vendor fostered a transparent and efficient process.
- Detailed reporting: The audit report produced by our team provided an in-depth analysis of the vendor’s processes and procedures, and audit observations were explained in full to allow for effective corrective and preventive actions (CAPA) to be raised and managed by the client.
Conclusion
This case study demonstrates the critical role of third-party vendor audits in maintaining GLP compliance within the pharmaceutical industry.
At Arithmos, we offer a comprehensive suite of GLP audit services to support healthcare companies to ensure the quality and integrity of non-clinical laboratory data. We can help you with:
- Assess your vendor’s GLP compliance status
- Identify and address potential compliance gaps
- Develop and implement effective CAPAs
- Prepare your organisation for successful regulatory inspections
By partnering with us, you can gain peace of mind knowing your data is generated in a GLP-compliant environment, reducing risks and ensuring the smooth progression of your product development programs.
About the Author
Laura Wilson
GxP Auditor and QMS Specialist
With a degree in Neuroscience and 5 years of experience working to Good Clinical Practice guidelines, Laura Wilson has worked with CROs, NHS sites and academic institutions to promote quality assurance in clinical research.
Laura Wilson works in Arithmos as our GxP Auditor and QMS Specialist.
She has built multiple client Quality Management Systems, delivered GCP training to clients for inspection readiness, and worked on both internal and external audits on behalf of a range of clients.
Co – Author
Michelle Anderson
GLP Auditor
After many years of experience working in a variety of laboratories both in academia and for CRO’s, Michelle Anderson was the Quality Assurance Manager for a CRO, in which she managed all aspects of the Quality Management System, ensuring regulatory compliance of ISO 9001:2015, conducting internal and external audits as well as managing customer complaints and problem solving.
Before joining Arithmos’ UK Quality Assurance Team as GLP Auditor, Michelle was a GLP Auditor for a global life sciences and healthcare company.
About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical R&D, Quality Assurance, Drug Safety & Pharmacovigilance, Regulatory and Medical Affairs.
