Receiving inspection checklist for a first peptide shipment

Why the first delivery needs a written inspection

The first shipment from a new supplier is the one with the least history behind it. If a label, lot number or certificate is wrong, you want to find out at the bench before the material is mixed into stock or used in an experiment, not weeks later when results look odd.

The clearest public model for receiving is ICH Q7, the GMP guidance for active pharmaceutical ingredients that FDA publishes. It says each container should be examined visually on receipt for correct labeling, container damage, broken seals and evidence of tampering or contamination, and held in quarantine until it has been sampled, examined or tested as appropriate and released for use. [1] A research laboratory is not shown to be bound by Q7. This guide borrows its order of checks and its vocabulary because they are specific and publicly available.

This page covers laboratory documentation only. It gives no guidance on preparing or using any peptide.

Before the box arrives

Prepare three things in advance: the purchase order or order confirmation, the certificate of analysis the supplier says applies (or a note that none was supplied before shipping), and a labeled quarantine location that matches the storage condition the supplier states. Decide who may sign a release. Q7 recommends that the persons authorized to release materials be specified, and that quality-related activities be recorded at the time they are performed. [1]

Assign the incoming lot a receipt number before you open it. Q7 recommends that each container or grouping of containers be identified with a distinctive code, batch or receipt number used to record its disposition, with a system showing the status of each batch. [1] In a small lab this can be one line in a spreadsheet: receipt number, date, supplier, status.

At the bench: the inspection in order

Work through the checks in a fixed order so nothing is skipped when the delivery arrives at a busy moment. Record what you see, not what you conclude. "Coolant pack fully liquid on opening, outer box dry" is an observation; "temperature fine" is not.

Label against purchase order against certificate

The three-way match is the core of the inspection. The purchase order says what you asked for, the container label says what was packed, and the certificate says what was tested. Q7 says a certificate should give the material name, grade where appropriate, batch number, date of release, and the expiry or retest date, list each test with its acceptance limits and numerical results, be dated and signed by authorized quality personnel, and show the name, address and telephone number of the original manufacturer. Where a repacker or broker issues a new certificate, it should name the laboratory that did the analysis and reference the original manufacturer and batch certificate. [1]

Few research-supplier certificates contain all of that. Record each element as present, absent or unclear rather than treating the certificate as a pass or fail. The site's certificate-reading guide covers the individual lines in more detail.

Safety data sheets arriving with the shipment

Under the US Hazard Communication Standard, laboratory employers must maintain any safety data sheets received with incoming shipments of hazardous chemicals and keep them readily accessible to laboratory employees during each workshift. If a shipment labeled as a hazardous chemical arrives without a safety data sheet, the distributor or employer must obtain one from the manufacturer or importer as soon as possible. [2]

File the sheet with the receipt record and note its revision date. If the supplier says the product is not classified as hazardous, keep that statement too. The safety data sheet guide in this section explains what each of the 16 sections should contain.

Quarantine, identity and the release record

Q7 defines quarantine as materials isolated physically or by other effective means pending a decision on approval or rejection. [1] For a lab, that means a marked shelf or box and a status of "quarantine" in the receipt log until someone signs a release or rejection.

Q7 also recommends at least one identity test on each batch of incoming material, and allows a supplier certificate to replace other tests only where the manufacturer has a system to evaluate suppliers, with complete analyses on at least three batches before reducing in-house testing. [1] Decide your own rule in writing before the first delivery: for example, release on a complete document match for routine reagents, but require an in-house or third-party identity check for a first lot from a new supplier. Then record which rule was applied.

A release record needs: receipt number, supplier lot, inspection results by line, open questions, decision (released, rejected or hold), who decided and when. A rejection should record what was done with the material.

A fictional first delivery

An invented shipment of two vials arrives. Outer box intact, seals intact, coolant pack partly thawed. Both vial labels show lot 2207; the certificate shows lot 2201. The purchase order said acetate salt; the label and certificate do not state a salt form. No safety data sheet is included.

The record reads: "Receipt R-014. Packaging and seals intact. Coolant partly thawed at 14:10, observation only. Container lot 2207 does not match certificate lot 2201. Salt form not stated on label or certificate; acetate ordered. No SDS received; supplier asked for SDS or written hazard classification. Status: quarantine pending corrected certificate and salt-form confirmation." Nothing has been judged good or bad; every open question has a named next action.