Setting up an approved supplier list for research chemicals and peptides

What an approved supplier list does

The list is the output of a supplier-control process, not the process itself. Assessors working from SADCAS's ISO/IEC 17025 checklist look for a procedure and records covering criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers, and for action taken as a result of those evaluations. [1] ICH Q7 puts it from the manufacturer's side: have a system for evaluating suppliers of critical materials, and purchase materials against an agreed specification from suppliers approved by the quality unit. [2]

In practice each row on the list answers five questions: who is the supplier (legal entity, not storefront name), which materials they are approved for, what status they hold (approved, conditional, suspended, removed), where the evidence is filed, and when the approval is next reviewed. A supplier can be approved for one material and not another; a peptide storefront approved for catalogue peptides is not automatically approved for a reference standard.

For a small research group the list can be one controlled spreadsheet. What matters is that orders are checked against it and that changes to it are dated and attributed.

Approval criteria you can actually check

Write criteria as documents or facts you can verify, not impressions. For peptides, the most useful ones come from ICH Q7's description of a complete certificate of analysis: material name and grade, batch number, release date, each test with acceptance limits and numerical results, a date and signature from the quality unit, and the original manufacturer's name, address and telephone number. A certificate reissued by an agent or broker should name the laboratory that did the analysis and reference the original batch certificate. [2]

Add the supply-chain criteria: if the seller is not the manufacturer, the manufacturer's name and address should be known [2]; the supplier should provide an SDS with the initial shipment of a hazardous chemical, as OSHA requires of manufacturers and importers [5]; and any third-party laboratory named on a certificate should be accredited by a body found in the ILAC MRA signatory search, with the test in its scope. [4] Past quality history counts too: Q7 treats evidence that a manufacturer can consistently meet specifications as part of supplier approval. [2]

• Lot-matched certificate with method, limits, numerical results, date and signature [2]
• Original manufacturer identified when the seller is a distributor [2]
• SDS supplied with the first shipment [5]
• Testing laboratory accreditation and scope verified [4]
• Written answers to the supplier qualification questionnaire
• Delivery to your country confirmed in writing

Risk tiers, required documents and review intervals

Tiers stop the list from becoming either a rubber stamp or an impossible burden. Base the tier on how directly a material affects your results. The review intervals below are this guide's suggestions; neither the SADCAS ISO/IEC 17025 checklist nor ICH Q7 sets a number, and Q7 speaks of checking certificate reliability at regular intervals. [2] Pick intervals you will actually keep and write them into the SOP.

What goes in each supplier file

The file is what you show when someone asks why a supplier is on the list. ICH Q7's traceability list for agents, brokers and distributors is a ready-made checklist of what a buyer should be able to reconstruct for each lot: identity and address of the original manufacturer, purchase orders, transport documents, receipt documents, the material name, the manufacturer's batch number, all authentic certificates including the original manufacturer's, and the retest or expiry date. [2]

• Supplier legal name, address, contact and the date first approved
• Materials and tiers covered by the approval
• Questionnaire with dated answers and the documents that back them
• Example certificate for a recent lot and the testing-lab accreditation check [2] [4]
• SDS for each approved material [5]
• Receiving and nonconformance history, newest first
• Review log: date, reviewer, outcome, next review date [1]

Conditional approval and building trust in certificates

New suppliers rarely arrive with enough history for full approval. A conditional status lets you buy while you collect evidence, with tighter checks. ICH Q7 recommends full analysis on at least three batches before reducing in-house testing, and even then a complete analysis at appropriate intervals compared against the supplier's certificates. [2] FDA's drug GMP rule takes the same line: rely on a supplier's report of analysis only with at least one specific identity test and periodic validation of the supplier's results. [3]

A research lab will rarely run full analysis on three lots of every peptide, and that is a cost decision to make openly. A realistic conditional rule might be: identity confirmed in-house or by an accredited lab on each of the first three lots, certificate matched to lot every time, and promotion to approved only after three lots without a nonconformance. Write the rule down so the next person applies it the same way.

Removal triggers and requalification

Decide in advance what suspends a supplier so the decision is not made under deadline pressure. 17025 expects action to be taken from evaluations and re-evaluations, and that action should appear in the review log. [1] Suspension blocks new orders; removal ends the approval and keeps the file for the retention period.

Requalification is the approval process run again with fresh evidence, not a phone call. A supplier removed for a lot mismatch should provide a corrected certificate and an explanation of the cause before any new order.

• Certificate lot number does not match the received lot
• Certificate cannot be traced to a named laboratory, or the lab is not accredited for that test [2] [4]
• Manufacturer identity withheld after request [2]
• Change in source, salt form or method not notified
• Failed identity check or repeated damaged deliveries
• Complaint left unanswered beyond the period your SOP allows