Good Laboratory Practice (GLP) Audits: Ensuring Compliance and Data Integrity
Our Good Laboratory Practice (GLP) audits focus on ensuring that laboratories comply with regulatory standards for non-clinical studies. We specialize in assessing supplier quality to enhance the credibility and reliability of data submitted for regulatory purposes.
Key Areas of Assessment:
- Laboratory Operations: We assess the efficiency and compliance of lab processes.
- Standard Operating Procedures (SOPs): Ensure SOPs are properly followed and updated.
- Facilities and Equipment: Ensure facilities are suitable and equipment is properly maintained and calibrated.
- Quality Assurance Protocols: Review your quality assurance processes to ensure they meet regulatory standards.
What is GLP?
Good Laboratory Practice (GLP) is a set of principles aimed at ensuring the reliability, consistency, and integrity of lab studies. Originally established in the 1970s, Good Laboratory Practices provides a framework for lab operations to produce credible and reproducible results.
The core focus of the GLP regulations is on the following aspects involved in Pharmaceutical or Life Science lab testing:
• The organization
• Personnel
• Facilities
• Equipment
• Operational procedures
It is designed to make sure that lab data is accurate, reliable, and can be used to support regulatory submissions and scientific research.
What is cGLP Compliance?
Current Good Laboratory Practice (cGLP) is the updated version of Good Laboratory Practices standards.
cGLP represents a more modern approach to lab testing that reflects current industry standards and practices. It builds on the foundational principles of traditional GLP regulations but includes regular updates to address new knowledge, innovations, and changes in regulatory guidelines. It incorporates the latest technological advancements, regulatory requirements, and best practices.
Our GLP Audit Approach
At RxCloud, we integrate foundational principles and cutting-edge practices to ensure the highest standards in lab testing. Our approach includes:
1. Adherence to cGLP Standards
We follow the most current Good Laboratory Practices compliance guidelines to ensure compliance with the latest regulations and technological advancements.
2. Comprehensive Assessments
Our GLP audits cover all critical aspects of lab operations, from personnel training to equipment calibration.
3. Continuous Improvement
We focus on ongoing improvements in quality assurance protocols to keep pace with evolving industry standards.
4. Regulatory Expertise
Our team is well-versed in both historical and current GLP regulations, ensuring that your studies are compliant and reliable.
By combining the robust framework of traditional GLP with the flexibility and updates of cGLP, RxCloud provides unparalleled assurance in data integrity and study reliability.
Contact us today to get started.
Want RxCloud to take charge of your GLP Compliance, & secure your data integrity and study quality?