Handling Quality Disputes Through Independent Retesting

01

Open one documented dispute record

A quality dispute should begin with an identifiable order, product and batch—not a general statement that the material did not meet expectations.

Create one record that preserves the original complaint, dates, contacts, requested remedy and every later decision. This prevents the investigation from being split across informal messages.

• Order and invoice reference
• Product and batch number
• Quantity and packaging condition
• Date received and date reported
• Description of the alleged nonconformance
• Photos, records or test data supplied by the buyer

02

Compare the claim with the agreed specification

A dispute can only be evaluated against an agreed requirement. Compare the complaint with the quotation, specification, label, COA and any acceptance criteria agreed for the order.

An unexpected research outcome is not automatically a product-quality failure. The investigation must identify the measurable attribute alleged to be outside the agreement.

03

Preserve the sample and chain of custody

Record whether the original container is available, whether it was opened, how it was stored and how much material remains. A retained manufacturer sample and a customer-held sample may answer different questions.

Before sending material to a laboratory, document the selected sample, seal, packaging, sender, receiver and dates. If sample condition is disputed, resolve that issue before interpreting a test result.

04

Complete the initial investigation before retesting

Review product, batch, packaging and shipping records first. Check for a labeling discrepancy, damaged packaging, quantity issue, storage excursion or document mismatch.

FDA’s OOS guidance, for pharmaceutical production within its scope, emphasizes a scientifically sound investigation rather than repeated testing until a passing result appears. That principle is useful for commercial dispute design even when the transaction is outside pharmaceutical CGMP.

05

Agree on the independent laboratory in writing

Stablize Peptides may use Freedom Diagnostics Testing or Vanguard Laboratory for an actual quality dispute. Selection occurs only after the dispute exists and the parties agree on the laboratory and scope.

The laboratory’s service, method, sample requirement, timing and report format should be confirmed. A laboratory name must not be treated as an endorsement of unrelated products or batches.

06

Define the test plan and decision rule

Write down the tested attribute, method, sample identity, number of tests, acceptance criterion and how conflicting results will be handled. Do this before the result is known.

Independent does not mean undefined. Without a pre-agreed rule, both parties may accept only the result they prefer.

07

Allocate fees and remedy before testing

The parties should agree who pays shipping, laboratory, broker and related costs under each possible outcome. The user-confirmed Stablize Peptides policy assigns all resulting costs according to the written outcome rule.

When the agreed independent retest supports a valid quality claim, the confirmed remedy is a refund. The scope and payment path should be recorded in the transaction terms.

08

Close the record and retain the conclusion

The final record should state the evidence reviewed, test result, decision, remedy, fees and date of closure. Any corrective action should be assigned to a responsible person.

For APIs within its scope, ICH Q7 describes written investigation of quality complaints and retention of complaint records to evaluate trends. The same disciplined closure prevents recurring commercial disputes from being treated as isolated messages.

RELATED GUIDANCE

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