Comprehensive Supplier Qualification & GxP Audits
PharmExpert provides independent, risk-based supplier qualification and GxP audits across the global pharmaceutical, healthcare and life sciences supply chain.
Overview
Audits cover APIs, Key Starting Materials (KSMs), intermediates, excipients, CMO/CDMOs, packaging materials, contract laboratories, warehousing, transportation and logistics (GDP), medical devices, nutritional supplements, cosmetics and EHS — conducted in accordance with applicable global regulatory requirements and industry standards.
Our lead auditors assess the site against the framework that matters for your supply chain — EU GMP Parts I and II, US FDA 21 CFR Parts 210/211, ICH Q7 for APIs, WHO TRS guidance and PIC/S. We examine the pharmaceutical quality system end to end: premises and utilities, equipment qualification and process validation, materials management and production controls, the quality-control laboratory, documentation and data integrity, and the maturity of the site's own self-inspection and CAPA culture. Nothing material is taken on trust; findings are grounded in records, observation and interview.
What distinguishes a PharmExpert audit is genuine independence. Because we manufacture nothing and sell no products, there is no commercial incentive to soften a finding or inflate a concern — you receive a candid assessment calibrated to real risk. Every observation is risk-ranked as critical, major or minor, tied to a specific regulatory clause, and accompanied by remediation direction your team can act on, so the report is a tool for decisions rather than a list of complaints.
From Raw Materials to Distribution, We Deliver Independent Audit Expertise to Strengthen Quality, Compliance, and Supply Chain Confidence.
What we do
- Pre-audit document review (Site Master File, prior inspection history, CAPAs)
- On-site or remote/hybrid audit execution by a qualified lead auditor
- Assessment of premises, utilities, equipment qualification and process validation
- Review of materials management, production controls and batch records
- QC laboratory, OOS/OOT handling and stability-program evaluation
- Data-integrity and documentation review against ALCOA+ principles
- Risk-ranked findings mapped to EU GMP / 21 CFR 211 / ICH Q7 clauses
Our process
- 1
Scope & schedule
Define audit type, applicable regulations, agenda and logistics; agree confidentiality and access.
- 2
Prepare
Review the SMF, prior findings and key SOPs so on-site time targets real risk.
- 3
Execute
Conduct opening meeting, facility tour, system-by-system review and daily debriefs.
- 4
Report & follow up
Issue a risk-ranked report and review CAPA responses to verified closure.
What you receive
- Formal GMP audit report with executive summary and risk-ranked observations
- Per-finding regulatory references and recommended corrective direction
- Audit plan, agenda and attendee log
- Entry in the verifiable audit-report database for shared-audit reuse
Who needs this
Marketing authorization holders and procurement teams qualifying a new contract manufacturer or API supplier; quality units preparing a site for an FDA, EMA or WHO inspection; and companies needing ongoing periodic GMP oversight of their network without a large internal audit function.
Frequently asked questions
Ready to improve your compliance?
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.