GxP Audits & Supply Chain
Rigorous compliance auditing across GMP, GCP, GLP and GDP frameworks, covering every product category in your supply chain.
Independent Auditing Across the Full Supply Chain
Your supply chain is only as compliant as its weakest supplier. We audit manufacturers, contract laboratories, distributors and material suppliers against the framework that applies to them — GMP for manufacture, GDP for distribution, GLP for testing and GCP for clinical activity.
Because we hold no commercial interest in any site we audit, our reports say what we actually found. That independence is what makes them defensible when an authority asks how you qualified a supplier.
At a Glance
- Sterile & non-sterile medicinal products
- API and API intermediates
- Contract laboratories & GDP distributors
Need this scoped for your facility and target market? A senior consultant will give you a candid read at no cost.
Request a ProposalProducts & Sites We Audit
Seven categories covered under a single qualification programme.
Medicinal Products
Sterile and non-sterile finished dosage forms across solid, liquid and parenteral lines.
API & API Intermediates
Active substance manufacture and intermediate synthesis steps.
Contract Testing Laboratories
Analytical, microbiological and stability testing service providers.
Distributors (GDP)
Wholesale dealers, logistics providers and temperature-controlled distribution chains.
Packaging Materials
Primary and secondary packaging component manufacturers and printers.
Biological & Cosmetic Products
Biologicals, vaccines and cosmetic manufacturing operations.
Excipients, KSMs & Raw Materials
Excipient producers, key starting materials and raw material suppliers.
Our Seven-Step Auditing Process
A defined methodology from planning through closure and re-verification.
Pre-Audit Preparation
Review of the site dossier, previous findings, product portfolio and applicable regulatory framework. The audit plan and agenda are agreed before travel.
Audit Arrangement
Formal scheduling with the auditee, confirmation of scope, required attendees, translation needs and document availability.
Conducting the Audit
On-site execution covering facility walkthrough, system review, documentation sampling, personnel interviews and data integrity verification.
Audit Reporting
A structured report classifying findings by criticality with clear regulatory references.
Preliminary report in 1 week · Comprehensive report in 4–5 weeksCAPA & Compliance Follow-Up
Review of the auditee’s corrective and preventive action plan, assessment of root cause adequacy and evidence of implementation.
Audit Closure
Formal closure once CAPAs are verified as effective, with the qualification decision documented for your supplier file.
Follow-Up Audits
Periodic re-audit to confirm sustained compliance and capture changes to the site, process or product range.
Standard cycle: every 3 yearsServices That Pair With This
Ready to Transform Your GxP Strategy?
Book a no-obligation consultation and get practical answers about gxp audits & supply chain for your specific product, facility and target market.