GLP, GCP, PV, CLIA and BIMO Audits

  • Overview
  • Benefits
  • Why Work With NSF?

Our team of expert consultants is experienced in conducting Good Laboratory Practice (GLP), Good Clinical Practice (GCP), pharmacovigilance (PV) and bioresearch monitoring (BIMO) audits as well as Clinical Laboratory Improvement Amendments (CLIA) assessments. These services assure compliance with regulatory requirements and industry best practices for laboratories and clinical research. Our consultants can conduct gap analyses, mock regulatory agency inspections, training and other activities to ensure that research and laboratory standards are met.

Our team of former regulatory agency staff and current R&D professionals and laboratory scientists has the breadth of knowledge, experience and skills to ensure that you receive a best-in-class audit of your laboratory and clinical activities, wherever you are in the world.

Benefits

Our global team of former regulatory agency staff and current R&D professionals and laboratory scientists has the experience, knowledge and skills to ensure that you receive a best-in-class audit of your laboratory and clinical activities regardless of where your company is based.

Why Work With NSF?

This case study provides a real-world example of how working with us can help your company.

Challenge: At the request of our client, a company developing therapeutics in the areas of thrombosis, other hematologic disorders and inflammation, we conducted a Good Laboratory Practices (GLP) audit at its contract research organization (CRO).

Solution: The audit assessed the CRO’s current systems, documentation and practices for compliance with existing standard operating procedures (SOPs) and FDA current GLPs for non-clinical studies, 21 CFR Part 58. We audited all applicable areas of site operations according to the FDA’s quality systems approach, including:

  • GLP facilities
  • Testing facility operations
  • Regulatory records procedures
  • Test article storage and documentation
  • Document control operations
  • Employee training program (including turnover) and training records/CVs
  • Laboratory equipment control
  • Protocol for and conduct of a nonclinical laboratory study

There were no adverse observations or inspectional findings. The CRO research facility, systems, practices and documentation related to the studies demonstrated an adequate quality system approach that operated in compliance with the study protocols, their SOPs and the FDA’s current GLPs.

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