Good Laboratory Practice (GLP) is a quality system applied to non-clinical health and environmental safety studies during the development of new products such as medicines, cosmetics, food products, industrial chemicals and pesticides. GLP provides assurance that study data submitted to regulatory authorities is accurate, valid, reliable and integrity.

Pharmatek has a robust GLP team of experts and has the experience and capability to conduct audits across the globe for all types including pre-study site qualification, facility, process, study specific data and reports, archive, niche services against GLP requirements. These GLP audits are conducted to ensure  compliance with FDA, EU regulations and guidelines ( 21 CFR Part 58, OECD guidelines).

Our team of experts has worked with laboratories and conducted audits of central laboratories and bio-analytical laboratories for routine and specialized analysis in compliance with GLP regulations.

Our audits are conducted in coordination with your team members 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 independent 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. This is accomplished through various forms of communication, including site visits, as needed. Clients are immediately notified of critical audit findings.

Pharmatek provides a wide range of GLP audit services to clients as per their specific needs.

Range of services

• 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