In non-clinical health and environmental safety, OECD Good Laboratory Practice (GLP) is the leading standard. For pharmaceutical, chemical, and agrochemical companies, as well as CROs, compliance with OECD GLP is essential for data integrity and acceptance by global regulatory authorities such as the FDA, EMA, and MHRA.
Maintaining GLP compliance across multiple global sites presents significant logistical and technical challenges. Ensuring consistent standards across all locations is critical for regulatory acceptance.
Who We Are
We are GxP Cellators, a consultancy specializing in GxP environments. Our focus on quality assurance and regulatory compliance helps organizations validate their GLP operations.
Unlike many consultancies that provide only guidance, we deliver hands-on execution. Our experienced auditors specialize in OECD GLP auditing, aligning regulatory expectations with operational practices.
Comprehensive OECD GLP Audit Services
Navigating the OECD principles (No. 1, No. 17, No. 22, and others) requires specialized expertise. We offer comprehensive services to protect the integrity of your non-clinical safety data, focusing on two key areas:
1. GLP Gap Assessments
Before an audit, it is essential to identify potential weaknesses. We conduct thorough GLP Gap Assessments to benchmark your processes against OECD Principles and identify discrepancies in:
- Personnel and training records.
- Facility design and environmental controls.
- Equipment calibration and maintenance.
- Test systems (biological, chemical, physical).
- Standard Operating Procedures (SOPs) and documentation practices.
Early identification of gaps allows clients to address issues before they lead to regulatory findings or study rejections.
2. Facility and Site Audits (On Behalf of the Client)
We provide independent audit services on behalf of our clients.
Whether you outsource studies to a CRO or operate internal test sites, maintaining objectivity is essential. We serve as your surrogate Quality Assurance Unit (QAU), conducting independent audits at test facilities and sites worldwide to ensure:
- Study Conduct: The study is performed in accordance with the protocol and OECD Principles.
- Data Integrity: Raw data is accurately recorded, verified, and secure.
- Facility Inspection: The physical infrastructure meets the required standards for non-clinical safety studies.
- Subcontractor Oversight: Third-party vendors and subcontractors used by the test facility are also in compliance.
Engaging our team provides clients with an unbiased, expert perspective without the cost of maintaining a global in-house auditing team.
A Global Reach
Compliance requirements extend globally. We deploy auditors worldwide and understand local regulatory nuances while upholding the OECD framework.
Our global presence ensures your studies meet regulatory standards and that your data will withstand regulatory scrutiny.
Why Partner with Us
Given that a single data integrity issue can significantly delay product launches, our services offer distinct advantages:
- Specialization: Our expertise is focused on GxP compliance rather than broad consulting.
- Objectivity: As third-party auditors, we deliver unbiased findings to help you accurately assess your facilities.
- Proactive Risk Mitigation: Our assessments and audits identify issues early, enabling timely corrective actions and reducing regulatory risk.
Contact for GLP Auditing
Regulatory approval depends on compliant data. As outsourced testing and global development increase, rigorous, independent oversight of OECD GLP facilities is essential. Ensure your test facilities and sites meet the highest standards of quality and integrity. Contact us today to discuss your OECD GLP auditing needs.
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