Good Laboratory Practice – Preparation and Measurement
Good Laboratory Practice provides assurance that study data submitted to regulatory authorities is accurate, valid, reliable, and has integrity.
Pharmatek has a robust team of experts with the experience and capability to conduct audits across the globe. Our audit capabilities include pre-study site qualification, facility inspections, process analysis, study specific data and reports, data archival, and niche services. GLP audits are conducted with FDA and EU regulations and guidelines (21 CFR Part 58, OECD) as the standard by which they’re conducted.
With experience conducting audits of central laboratories and bio-analytical laboratories for routine and specialized analysis, we work in coordination with your team to make sure that the audit meets your company’s specific needs. Our experts will work with your organization to create a customized audit agenda and to conduct a systematic and tailored audit.
Our highly experienced auditors conduct independent assessments and can assist with remediation of any problems discovered. We focus on maintaining close contact with our clients, conducting site visits, and making clients immediately aware of critical audit findings.
Our range of Laboratory audit services include:
- Vendor Qualification audits or Re-qualification audits
- Facility audits
- Process audits
- Study audits
- Bioanalytical laboratory audits
- Central Laboratory audits
- Protocol audits
- Data audits
- Report audits
- Archive audits
