Writing a peptide procurement SOP: sections, owners and records

What the SOP has to prove

An accreditation body's checklist is a good way to see what an assessor will look for. SADCAS form F 60(a), which walks assessors through ISO/IEC 17025:2017 management requirements, frames clause 6.6.1 as ensuring that suitable externally provided products and services that affect the laboratory are used. Clause 6.6.2 asks for a procedure and records for defining, reviewing and approving the laboratory's requirements; defining criteria for evaluation, selection, monitoring of performance and re-evaluation of providers; ensuring products conform to the laboratory's requirements; and taking action from those evaluations. Clause 6.6.3 asks the laboratory to communicate to providers the products to be supplied, the acceptance criteria and any required competence. [1]

Clause 8.4 covers records: establish and retain legible records, and control their identification, storage, protection, backup, archive, retrieval, retention time and disposal, keeping them for a period consistent with contractual obligations. [1] ICH Q7 makes the same point from the manufacturing side, recommending written procedures for the receipt, identification, quarantine, storage, handling, sampling, testing and approval or rejection of materials. [2]

A research lab that is not accredited can still use this structure. It gives an auditor, a funder or a new staff member a familiar map, and it forces every step to name a person and produce a record. If your quality system is built on a different standard, keep the sections and map the clause numbers yourself.

Section-by-section outline

The table is the skeleton of the SOP. Each row becomes a numbered section; the owner column becomes a role, not a person's name, so the SOP survives staff changes.

Template text: scope, roles, supplier approval and ordering

Replace the words in capitals with your own. Scope: This procedure applies to the purchase of synthetic peptides and peptide reference materials for laboratory research by LAB NAME at SITE. It covers supplier approval, ordering, receiving, quarantine, release, storage, nonconformance and records. It does not cover use of the material.

Roles: The PRINCIPAL INVESTIGATOR approves this procedure and any change to it. The QUALITY LEAD maintains the approved supplier list and supplier files. The REQUESTER raises orders. The RECEIVER logs deliveries. The RELEASER, who must not be the requester for the same order, moves material from quarantine to use. Each role has a named deputy.

Supplier approval: Material is ordered only from suppliers on the approved supplier list for that material type. To be approved, a supplier must provide the documents listed in the supplier-approval annex, and approval is reviewed at the interval set for its risk tier. This follows the 17025 expectation of defined criteria for evaluation, selection, monitoring and re-evaluation, and the Q7 practice of purchasing against an agreed specification from suppliers approved by the quality unit. [1] [2]

Ordering: Each purchase order states the sequence and modifications, salt form, quantity basis, required documents (lot-matched certificate with method, laboratory, date and signature; current SDS) and the acceptance criteria. Stating them on the order is how the lab communicates its requirements and acceptance criteria to the provider. [1]

Template text: receiving, quarantine and release

Receiving: On arrival the RECEIVER checks each container for correct labelling, matching names between label and order, damage, broken seals and signs of tampering, records the condition, and assigns a receipt number that is used for every later record of that container. [2]

Quarantine: All received material is placed in the quarantine location under its labelled storage condition and marked not released. It stays there until the RELEASER completes the release checks. [2]

Release: The RELEASER confirms that the certificate matches the received lot number, that the tests and acceptance limits meet the order, and that the identity check required for this risk tier is complete, then records the release. As a model, ICH Q7 expects at least one identity test per batch and allows a supplier certificate in place of other tests only where a supplier-evaluation system exists. [2] FDA's drug GMP rule takes the same approach: a manufacturer may accept a supplier's report of analysis if it runs at least one specific identity test and validates the supplier's results at appropriate intervals. [3] A research lab may set a lighter rule, but the SOP should say what it is.

Template text: storage, nonconformance and change

Storage: Released material is stored at the condition stated in the supplier documentation. Supplier labels are not removed or defaced, and the SDS received with each shipment is kept where lab staff can reach it, as OSHA's laboratory standard requires for hazardous chemicals. [4]

Nonconformance: A nonconformance is any wrong or missing document, a lot mismatch, damaged or tampered packaging, a failed identity check, or a storage excursion. The material is kept in quarantine, the QUALITY LEAD records the issue and notifies the supplier in writing, and the final disposition (return, destroy, accept with justification) is recorded. As a model, Q7 recommends that intermediates and APIs failing their specifications be identified as such and quarantined, and that the final disposition of rejected material be recorded. [2]

Change: Any change of supplier, specification, salt form or test method is treated as a change. Q7 recommends written procedures to identify, document, review and approve changes, and, once a change is approved, revising every document it affects. [2] The SOP should list where supplier names appear (approved supplier list, order templates, inventory, methods text) so none is missed.

Records retention and review cadence

Write retention as a table in the SOP annex rather than a sentence. 17025 asks for controls on retention time and disposal and a period consistent with contractual obligations. [1] For US federal awards, 2 CFR 200.334 sets three years from submission of the final financial report, extended for litigation, claims, audits or a written request. [5] Q7 suggests at least one year after a batch's expiry date for production and control records. [2] Take the longest that applies.

Keep SDSs in the workplace for each hazardous chemical, as the hazard communication rule requires. [6] Review the SOP at a fixed interval and after any nonconformance or supplier change; the interval is your choice, and a yearly review is easy to tie to an annual budget cycle.