Log: Approved Vendor List (AVL) for GxP Materials and Services

This is a ready-to-use controlled register for GxP material, component, and service suppliers, the single reference procurement, receiving, and QA check before an order is placed or a lot is accepted.

It covers materials and services generally; for GxP software suppliers specifically, use the approved supplier list for GxP software, which carries fields this register does not (product version, GAMP category, CSA reliance level). Replace every <<FILL: ...>> placeholder with your own specifics. A filled specimen follows. This is general guidance to adapt to your own supplier qualification program and verify, not legal or regulatory advice.

1. Purpose and ownership

The AVL is a controlled document, not a working spreadsheet anyone can edit. Only suppliers on this register, within the scope stated for them, may supply GxP materials or services. Ownership sits with <<FILL: role, e.g. Head of Quality Assurance>>. Procurement may request an addition, a scope change, or a removal; only the document owner or a delegate executes the change.

2. Field list

3. Instructions

1. Add a supplier only after a completed qualification record exists (questionnaire, documentation review, audit where required, quality agreement where required, QA approval). Do not add a supplier on the strength of a purchase order already placed.
2. State the scope precisely: the specific material and grade, or the specific service, and the specific site. A supplier approved for one site or one grade is not approved for another without a separate scope entry.
3. Record every edit in the change history, including the reason. An AVL with no change history cannot demonstrate what it said on the date a specific lot was purchased.
4. Reconcile this register against actual purchase orders and receiving records on a defined schedule, <<FILL: e.g. quarterly>>, and investigate any off-list purchase found, rather than silently correcting the record.
5. When a supplier’s status changes to Suspended or Disqualified, update this register the same day the decision is made; do not let the register lag the actual decision.

4. Retention

Retain this register, including every prior version and the full change history, for <<FILL: retention period, e.g. the life of the product plus regulatory minimum>>, per the records retention schedule. Retain superseded versions in a retrievable form so a specific historical entry can be reconstructed on request.

5. Register

6. Change history

Filled specimen

The following shows four illustrative register rows, so you can see the level of detail expected. The suppliers, sites, people, and reference numbers are invented for illustration; replace them with your own.

Change history extract

Common inspection findings this register prevents

• A “current” AVL that does not match what receiving and purchasing records actually show.
• No change history, so an inspector cannot confirm what the register said on the date a specific lot was bought.
• A disqualified supplier’s row left in an “Approved” state because the register was not updated the day the decision was made.
• Procurement editing the register directly, bypassing QA ownership.

How to adapt this register

1. Set your document owner and reconciliation schedule.
2. If your system is electronic (a QMS module or a validated spreadsheet with access controls), map these fields onto it and confirm the electronic system itself meets your audit trail requirements; do not run a parallel manual register once the electronic one is live.
3. Align the tier values here with your supplier risk tier classification assessment so the two records agree.