Supplier Qualification
Independent Supplier Qualification Audits
Your approved supplier list is only as strong as the evidence behind it. Vitalane conducts independent GMP audits of API suppliers, excipient suppliers, packaging suppliers, and contract laboratories — giving brand owners and sponsors objective, inspection-ready assurance.
Why Independent Supplier Audits Matter
Outsourcing supply does not outsource accountability. Regulators expect brand owners to demonstrate active oversight of every supplier in their network.
Regulatory accountability stays with you
The TGA, FDA, and EMA do not accept "my supplier told me they were compliant" as a defence. Brand owners and sponsors must demonstrate active supplier oversight — and an independent audit is the most credible way to do that.
No conflict of interest
Vitalane has no commercial relationship with the suppliers it audits. Findings reflect what the evidence shows — not what a supplier wants on their audit report.
Inspection-ready documentation
Audit reports are structured to withstand regulatory scrutiny. If a TGA or FDA inspector asks to see your supplier qualification records, you have objective, risk-rated evidence ready.
Delivered by Bright Gnanaselvam directly
Every supplier audit is conducted and reported by Bright — not delegated to a junior associate. Clients work directly with the practitioner throughout the engagement.
What the Audit Covers
Each engagement is scoped to your specific supplier type and regulatory requirements. Audit scope, standards applied, and report format are agreed before fieldwork begins.
Conducted by Bright Gnanaselvam — MSc Pharmaceutical Sciences, MRSC — directly.
- Initial qualification audits for new suppliers
- Periodic re-qualification audits for approved suppliers
- API and excipient supplier GMP audits
- Packaging supplier audits (primary and secondary)
- Contract testing laboratory (CLO) audits
- Risk-rated audit reports with findings mapped to TGA, FDA, EU GMP, or PIC/S
- Corrective action recommendations and follow-up
- Approved Supplier List (ASL) support documentation
Common Questions
Why do brand owners need independent supplier qualification audits?
Regulators including the TGA, FDA, and EMA hold brand owners and sponsors accountable for the quality of every ingredient and material in their products — regardless of who supplies them. An independent supplier qualification audit provides objective evidence that your approved supplier list is based on verified GMP compliance, not self-declarations.
What types of suppliers does Vitalane audit?
Vitalane audits API (active pharmaceutical ingredient) suppliers, excipient and raw material suppliers, primary and secondary packaging suppliers, contract testing and analytical laboratories, and contract research organisations (CROs) involved in product testing.
What does a supplier qualification audit report include?
Each audit report includes a risk-rated findings summary, observations mapped to the relevant regulatory standard (TGA, FDA, EU GMP, or PIC/S), a corrective action recommendation for each finding, and an overall supplier risk classification to support approved supplier list decisions.
Ready to Qualify Your Suppliers?
Book a short call with Bright to discuss your supplier network, audit scope, and timeline — no commitment required.