The release packet is the product.

Qualifying a lot

Four steps from sample to standing supply.

Review the sample COA, confirm your QA requirements, and agree the supply terms. Each supplied lot can be traced to its matching batch COA.

1. 01

   Request the sample COA + spec

   Send your catalogue request with your license class. We return a representative COA, the endotoxin / bioburden spec, and an ICH stability summary so your QA team can review the format before any material moves.

2. 02

   Qualify a sample lot

   Receive a sample lot and request its batch COA from sales. Reconcile the recorded results against your acceptance criteria; any incoming-material testing required by your own SOP remains optional and is not a Vialdyne condition of purchase.

3. 03

   Set acceptance criteria & onboard

   We agree the release specification and the documentation wrapper that matches your filing — 503A, 503B, EU Annex 1, or distributor — under mutual NDA / supply terms.

4. 04

   Standing supply, lot data each time

   For repeat orders, ask sales to confirm the current lot and provide its matching COA. Any additional documents remain governed by the written order scope, and documentation questions are handled through the regulatory / sales review.