GLP for pharma companies

Most pharma companies don't run GLP studies themselves — they sponsor them at CROs. That doesn't move the GLP obligation off your books: sponsors are expected to oversee the work, and inspection findings at your CRO become your problem.

Sponsor oversight is the job

GLP expects sponsors to assure the quality of outsourced studies. In practice that means: qualifying CROs before awarding studies, auditing them periodically (vendor audits), reviewing protocols and final reports, and tracking their inspection history. A sponsor with no vendor-audit program is an inspection finding waiting to happen.

Vendor audits: what to cover

• QA-unit independence and audit coverage of your study
• Study-director qualifications and authority
• Data integrity: audit trails, access controls, raw-data custody
• Archive arrangements — including what happens if the CRO closes or is acquired
• Prior inspection outcomes and how findings were closed

When to hire help

Independent auditors are commonly hired for for-cause vendor audits and for qualifying a new CRO before a pivotal study. Our directory includes firms like ADAMAS Consulting that list vendor and subcontractor inspections as a service. The consultant-vs-CRO comparison covers the build-vs-outsource decision for sponsors considering bringing work in-house.

Budgeting

Sponsor-side GLP costs are mostly vendor-audit days and oversight headcount. Use the cost guide's estimator for audit-day planning figures, and get scoped quotes via the quote form.