Wholesale Returns Assessment Record
Assessment record for the one routine transaction where product re-enters saleable stock from outside your control. Quarantine on receipt, positive evidence of storage conditions rather than the absence of a complaint, origin and entitlement checks, packaging and safety-feature inspection, a responsible-person decision against defined criteria, and returns analysed as data. Maps to EU GDP 2013/C 343/01 and WHO TRS 957 Annex 5.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A return is the one routine transaction where product re-enters saleable stock from outside your control, which makes it the natural entry point for falsified, mishandled and diverted medicines. The default answer is no, and the record exists to document what changed that answer. The failure mode is a return placed into pickable stock while the assessment is pending — the control is then decorative.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
The EU GDP Guidelines 2013/C 343/01 set the conditions under which returned medicinal products may go back into saleable stock, and place the decision with the responsible person; WHO TRS 957 Annex 5 carries the equivalent good storage and distribution expectations. Neither writes your criteria for you — the temperature evidence you will accept, the time out of control you treat as disqualifying, the features you inspect. Those are your determinations. The record structure here is SPEQ practitioner synthesis built to make each one explicit.