VaLogic

MYTH: If a supplier provides a Certificate of Analysis with every shipment, your incoming material qualification is covered.

REALITY: A CoA documents a result. It does not document the conditions under which that result was generated.

A compliant supplier audit program goes beyond document review. The questions that matter:

1. Is the supplier's test method equivalent to yours — or are they testing against their own internal specification, which may differ from yours?
2. Is their analytical equipment calibrated and qualified? When was it last qualified?
3. Who performs the testing — a dedicated QC function or production staff wearing multiple hats?
4. How does the supplier handle an OOS result internally? What is their investigation and release process?
5. What change control process governs method changes, equipment changes, or raw material substitutions — and would you be notified?

A supplier who consistently provides clean CoAs but cannot answer these questions is not a qualified supplier. They are an unaudited risk.

What question do you ask in supplier audits that others rarely think to ask?

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An Out-of-Specification Result Is Not Your Problem. A Weak Investigation Is.

Here is what FDA's two-phase OOS structure actually requires:

PHASE 1: Laboratory Investigation Rule out analyst error, instrument problems, and sample prep issues before touching the product conclusion. Document everything in real time. No retroactive investigations.

PHASE 2: Full-Scale Investigation If Phase 1 finds no lab cause, expand to manufacturing. Review the batch record, raw materials, and process parameters. Reach an actual root cause conclusion.

"No assignable cause found" is not a conclusion. It is a signal that Phase 2 was not thorough enough. Most OOS failures are process failures. Build the investigation program before you need it.

Our latest blog walks through the two-phase OOS investigation structure FDA expects, where programs typically break down, and what a defensible investigation record actually looks like.

Read the Full Blog: https://hubs.li/Q04nJhCP0