Good Clinical Lab Practice Services
Good Clinical Laboratory Practice is the critical quality standard that protects the reliability of data from your clinical trial laboratories. Getting it right is essential for regulatory approval and patient safety.
FDA Quality and Regulatory Consultants (FDAQRC) leverages a global expert network to help pharmaceutical and biotechnology companies establish compliant sample handling, validate analytical methods and ensure their data meets stringent Food and Drug Administration, European Medicines Agency, and other Global Health Authorities requirements. Our partnership provides you with the confidence that your laboratory operations will withstand scrutiny, protecting your investment and accelerating your path to approval.
How GCLP Differs From GLP and GCP
Good Clinical Lab Practice (GCLP) is a hybrid standard that bridges the gap between Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). While GCP governs the ethical conduct of clinical trials with human subjects and GLP applies to the safety of nonclinical studies, GCLP applies the rigorous laboratory practices of GLP to the analysis of human samples collected during a clinical trial.
The Core Principles of GCLP Compliance
GCLP compliance is built on several key principles. These include having clearly defined roles for qualified personnel, maintaining properly calibrated equipment and implementing a quality management system (QMS).
GCLP also mandates meticulous documentation, data integrity with clear audit trails and rigorous protocols for the entire sample management life cycle, from collection to storage and analysis.
End-to-End GCLP Compliance Services
We provide expert GCLP compliance services to help you maintain reliable, integral and fully compliant clinical trial data.
GCLP Audit Services
We perform rigorous audits of laboratories on behalf of sponsors, evaluating the lab’s quality system, sample management processes, vendor and subcontractor qualifications, and data integrity practices to identify compliance gaps. Based on the audit findings, we provide sponsors with a comprehensive report containing actionable recommendations to remediate those gaps.
Implementation and GCLP Remediation Support
Our consultants build and implement a comprehensive GCLP framework tailored to your laboratory’s unique challenges.
- CAPA planning and management: Our experts help in developing and managing Corrective and Preventive Action (CAPA) plans to address the compliance gaps we identify.
- SOP and policy development: We partner to create and refine standard operating procedures (SOPs) and quality policies for sample handling, biometrics testing and other processes.
- QMS development: Our team assists with the development and implementation of a reliable QMS.
Inspection Readiness
Our team will assist you in preparing your documentation and personnel for upcoming regulatory inspections. We simulate inspections to improve your organization’s readiness.
Customized GCLP Solutions for Clinical Development
We have designed our GCLP services to support the unique environments of pharmaceutical and biotechnology companies.
GCLP for Pharmaceutical Companies
Maintaining data consistency and vendor oversight for large pharmaceutical companies is a challenging task. We act as your partner to ensure quality across all your laboratory operations.
Our focus includes central lab oversight and management, global trial harmonization, and pharmacokinetic and pharmacodynamic data integrity.
GCLP for Biotechnology Companies
With biotechnology firms pioneering cutting-edge therapies, they need specialized and novel analytical methods. We tailor our services to this innovative environment by specializing in validating novel biomarker assays, navigating immunogenicity testing requirements and qualifying specialty and academic laboratories.
Why We Are Your Ideal GCLP Expert Consultants
Choosing us as your GCLP compliance partner means investing in a trustworthy consultant. We build lasting client relationships through a service experience that stands out in the industry.
We provide you with:
- White glove services: Our internal project management team guides every project, providing a single point of contact, meticulous oversight and proactive communication.
- Global expertise in laboratory compliance: With a global consultant network of seasoned, credentialed experts, you access practical, actionable guidance that solves your immediate compliance challenges across different regulatory environments.
- Tailored solutions for your specific needs: Since we understand that each business is unique, we customize our approaches to your application needs.
- Ongoing support and guidance: We assist you in implementing corrective actions, embedding a culture of continuous improvement and maintaining a constant state of inspection-readiness.
Contact FDAQRC for Expert GCLP Compliance Services
As your trusted GxP compliance expert, we are ready to support your company’s journey to complete compliance every step of the way. Fill out our contact form today to request an expert consultation.
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