This is a ready-to-use checklist for qualifying and periodically reassessing a wholesale distributor as a trading partner, a customer you sell to or an upstream supplier you buy from. It is deliberately different from a checklist you would run on a contracted 3PL. A 3PL is your subcontractor: you write its procedures and can walk its floor on demand. A wholesale distributor buys and resells product under its own license and its own Responsible Person (RP), so this checklist leans on documentary verification, licensing checks, and the quality agreement rather than assuming you can inspect their warehouse whenever you like. Replace every <<FILL: ...>> placeholder. A filled specimen follows. Verify each cited reference against the current source before you rely on it.
How to use
- Run sections A through F before the first shipment to a new wholesale account, and again at the periodic interval your supplier/customer qualification procedure sets (commonly every one to three years, risk-based on product value and diversion sensitivity).
- Run it for cause after a serialization mismatch, an unexplained return pattern, a complaint that implicates storage or handling, or a licensing lapse anywhere in the partner’s network.
- Where you lack direct audit access, accept documentary evidence (license register extract, attestation letter, summary mapping report) but record the evidence source for every item; an unverified claim is not the same as a verified one.
- This checklist does not replace the courier and 3PL cold chain qualification checklist or the 3PL data integrity audit checklist; use those for a contracted logistics provider you directly instruct, and use this one for a wholesale distributor that trades with you as an independent, licensed party.
Checklist control
| Field | Entry |
|---|---|
| Checklist number | <<FILL: CHK-ID>> |
| Wholesale distributor / trading partner | <<FILL: company name>> |
| Relationship type | <<FILL: customer we supply / supplier we buy from / both>> |
| Assessment type | <<FILL: initial qualification / periodic / for-cause>> |
| Assessor(s) | <<FILL>> |
| Date | <<FILL>> |
Section A: Licensing and registration
| # | Item | Pass / Fail / N/A | Evidence / answer |
|---|---|---|---|
| A1 | Wholesale Dealer’s Authorisation (WDA), state wholesale license, or equivalent is current and was verified against a public or competent-authority register, not accepted from the partner’s own statement alone | <<FILL>> | |
| A2 | License scope (product classes, controlled substances, storage conditions) covers the product being distributed | <<FILL>> | |
| A3 | License renewal date is tracked and re-verification is scheduled before it lapses | <<FILL>> | |
| A4 | Any prior regulatory action (license suspension, warning letter, inspection finding) against this partner was checked and assessed | <<FILL>> |
Section B: Responsible Person and accountability
| # | Item | Pass / Fail / N/A | Evidence / answer |
|---|---|---|---|
| B1 | A named Responsible Person (or equivalent accountable decision-maker) is on file, matching the license record | <<FILL>> | |
| B2 | The partner can describe, without prompting, who authorizes an excursion disposition or a returned-stock decision | <<FILL>> | |
| B3 | A delegation or deputy arrangement covers the RP’s absence | <<FILL>> |
Section C: Authorized sourcing and supply
| # | Item | Pass / Fail / N/A | Evidence / answer |
|---|---|---|---|
| C1 | The partner has a documented process for qualifying its own suppliers and customers as authorized parties before transacting | <<FILL>> | |
| C2 | Where a track-and-trace regime applies (DSCSA, EU FMD), the partner exchanges or verifies the required identifiers and records at change of ownership | <<FILL>> | |
| C3 | The partner has a defined process for suspect or illegitimate product, including notification back to you within a stated timeframe | <<FILL>> |
Section D: Storage and temperature capability (documentary review)
| # | Item | Pass / Fail / N/A | Evidence / answer |
|---|---|---|---|
| D1 | A temperature mapping report or equivalent qualification evidence exists for the storage areas holding this product, requested and reviewed, not merely referenced | <<FILL>> | |
| D2 | A monitoring and alarm system is described, with a stated response process for an excursion | <<FILL>> | |
| D3 | The partner’s excursion procedure states a disposition authority and references a stability-based decision, not a blanket release statement | <<FILL>> | |
| D4 | Where the relationship’s quality agreement grants audit rights, at least one physical or remote verification of storage conditions has occurred rather than relying on paper alone | <<FILL>> |
Section E: Security and product integrity
| # | Item | Pass / Fail / N/A | Evidence / answer |
|---|---|---|---|
| E1 | Storage areas holding this product have controlled access (not open-floor access for all staff) | <<FILL>> | |
| E2 | Custody handoffs (receipt and dispatch) are attributable to a named person or a controlled scan device, not a generic log entry | <<FILL>> | |
| E3 | The partner has a documented process for identifying and escalating suspected diversion, theft, or counterfeit product | <<FILL>> | |
| E4 | Inventory reconciliation (received versus shipped versus on-hand) is performed on a defined cadence and discrepancies are investigated | <<FILL>> |
Section F: Returns, recalls, and complaint responsiveness
| # | Item | Pass / Fail / N/A | Evidence / answer |
|---|---|---|---|
| F1 | The partner’s returns process matches the saleable-return conditions (demonstrable storage history, intact packaging, in-date, verifiable identifier) and defaults unmonitored returns to non-saleable | <<FILL>> | |
| F2 | The partner can execute a recall to its own downstream consignees and has either run a mock recall or can produce evidence of a real one, with a stated reconciliation timeframe | <<FILL>> | |
| F3 | A complaint received by the partner that implicates your product is forwarded to you within a stated timeframe | <<FILL>> |
Reference: weak versus strong answers to listen for
| You ask | Weak answer (finding) | Strong answer |
|---|---|---|
| How do we know your wholesale license is current? | ”Here is a copy from when we onboarded three years ago” | A recent register extract or attestation, re-verified against the competent authority |
| Who signs off on a returned unit going back to saleable stock? | ”Whoever is on the floor that day” | A named RP or delegate, with a documented decision gate |
| How would you know if product was diverted out of your network? | ”We would probably hear about it eventually” | A defined reconciliation cadence and an escalation process tied to inventory discrepancies |
| What happens if you receive a complaint about our product? | ”We handle it ourselves” | Forwarded to the manufacturer within a stated window, per the quality agreement |
Scoring and sign-off
| Field | Entry |
|---|---|
| Total items / Pass / Fail / NA | <<FILL>> |
| Findings routed to CAPA or qualification hold (numbers) | <<FILL>> |
| Overall verdict | <<FILL: qualified / conditionally qualified / not qualified>> |
| Next reassessment due | <<FILL>> |
| Role | Name | Signature | Date |
|---|---|---|---|
| Assessor | <<FILL>> | ||
| QA approval | <<FILL>> |
References
EU Guidelines on Good Distribution Practice (2013/C 343/01), Chapter 2 (Quality management, including the wholesale distributor’s own qualification duties) and Chapter 5 (Operations, sourcing and supplying only authorized parties). MHRA “Rules and Guidance for Pharmaceutical Distributors” (the Green Guide). Directive 2001/83/EC, Article 80 (wholesale distributor obligations) and Article 85b (brokering). Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act 2013); 21 CFR Part 205 (state wholesale licensing).
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
Illustrative qualification of a new wholesale distributor customer before a first shipment.
| # | Item | Pass / Fail / N/A | Evidence / answer |
|---|---|---|---|
| A1 | WDA current, verified against register | Pass | Verified against the national competent-authority register, 03 Sep 2026, license expires 2028 |
| B1 | Named RP on file | Pass | RP named on the WDA; contact confirmed by phone |
| C2 | Serialization verification process | Fail | No described process for verifying incoming product identifiers before resale; qualification made conditional |
| E2 | Attributable custody handoffs | Pass | Receipt confirmed by named warehouse operator scan, tied to a badge ID |
| F1 | Saleable-return default | Pass | Written procedure defaults unmonitored returns to non-saleable |
| Field | Entry |
|---|---|
| Wholesale distributor | MeridianRx Wholesale Ltd. |
| Relationship type | Customer we supply |
| Assessment type | Initial qualification |
| Overall verdict | Conditionally qualified, pending C2 remediation |
| Next reassessment due | 24 months, or for-cause |
| Assessor | J. Alvarez, signed, 12 Sep 2026 |
| QA approval | R. Gomez, signed, 15 Sep 2026 |
The C2 gap is the teaching case: everything about the partner’s license and physical operation was sound, but with no described process for verifying incoming serialized product before resale, an already-diverted or falsified pack could pass through unnoticed. First shipment was held pending a written remediation plan rather than waived on the strength of the rest of the checklist.
Common inspection findings this checklist surfaces
- A wholesale distributor customer or supplier never formally qualified, with license status assumed from a business relationship rather than verified.
- No named RP confirmed at the partner, or the RP on file does not match the current license record.
- The partner’s serialization verification process is undocumented or untested.
- Custody handoffs recorded as a generic delivery note with no attributable person or scan.
- Reassessment interval not tracked, so a lapsed license or an expired quality agreement goes unnoticed for years.
How to adapt this checklist
- Set the reassessment interval from the product’s diversion sensitivity and value, not a single fixed number for every partner.
- Where your relationship is supplier-facing rather than customer-facing, reverse the framing in sections C and F to what you require from them as your source of product.
- Attach the GDP quality agreement for a wholesale distributor relationship as the contractual basis for the audit rights this checklist exercises.
- Route every Fail to a qualification hold or CAPA, and confirm the current references before you rely on them; this is educational guidance, not regulatory advice.