Good Laboratory Practices (GLP)
Good Laboratory Practices – GLP Sponsor and Contract Laboratory Auditing & Qualification
ClinAudits offers unbiased, value-driven regulatory compliance auditing and consulting for GLP. We focus on maintaining close contact with our clients. This is accomplished through various forms of communication, including site visits, as needed. As per SOPs, clients are immediately notified of critical audit findings.
Good Laboratory Practices Audits
- GLP – Sponsor and contract laboratory auditing, qualification
- GLP laboratory design/validation
- Microbiological and analytical methods validation and protocol development
- Product testing and consultation to USP (United States Pharmacopoeia) requirements
- Laboratory SOP and methods development and review
- Testing facilities operations
- Test and control articles
- Records, reports and record/sample retention
- QA unit
- API/Raw Material qualification
- Lab equipment validation
- Microbiology laboratory and analytical chemistry consulting
- Mock FDA/EMA/MHRA auditing
- Stability protocol development
- GLP training for employees: Individual or group
