Template: GDP Quality (Technical) Agreement for a Wholesale Distributor Relationship

This is a ready-to-use base quality (technical) agreement for a relationship with a wholesale distributor, a trading partner that buys and resells your product, or supplies it to you, under its own license and its own Responsible Person (RP). It is a different document from the GDP / 3PL data integrity quality agreement addendum, which only bolts data-integrity clauses onto an existing logistics contract with a subcontracted 3PL. A wholesale distributor is not your subcontractor, so this template covers the fuller relationship: named accountable persons on both sides, authorized sourcing and supply, storage warranties, serialization obligations, suspect and falsified product handling, returns, recall cooperation, and audit rights. Replace every <<FILL: ...>> placeholder. A filled specimen of the key clauses follows. This content is educational and general, not legal advice; route it through your own legal and regulatory affairs functions before use.

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1. Purpose

This agreement states the GDP obligations each party owes the other for the products and markets in scope, so that quality, safety, and traceability are maintained across the change of ownership between the parties. Where this agreement and any commercial or supply contract conflict on a quality matter, this agreement governs.

2. Named accountable persons

Each party will notify the other in writing within <<FILL: number>> business days of any change to its named RP or delegate.

3. Authorized sourcing and supply

• Each party warrants that it sources product only from, and supplies product only to, authorized parties (holders of a valid manufacturing, wholesale, or dispensing authorization as applicable in the relevant jurisdiction).
• Each party will verify the other’s license status at the start of this agreement and at the reassessment interval stated in section 12, and will notify the other immediately of any suspension, revocation, or material change to its own license.
• Neither party will subcontract activities covered by this agreement to a further party without the other’s prior written approval and equivalent flow-down of this agreement’s quality terms.

4. Storage and transport conditions

• Party 2 warrants that product is stored and transported within its labeled conditions at all times it holds title or physical custody, using facilities that have been mapped or otherwise qualified for the conditions the product requires.
• On request, Party 2 will provide a summary of its storage qualification evidence (mapping report summary, monitoring system description) for the storage areas holding this product.
• Party 2 will use packaging and lanes appropriate to the product’s stability requirements for any onward transport it arranges.

5. Serialization and traceability

• Where a track-and-trace regime applies (US DSCSA, EU FMD/Delegated Regulation (EU) 2016/161, or an equivalent national scheme), each party will exchange or verify the required product identifiers, transaction records, or decommissioning events at every change of ownership, consistent with its obligations as a trading partner under that regime.
• Party 2 will maintain the aggregation and traceability records necessary to reconstruct the chain of custody for any lot on request.

6. Suspect, falsified, or illegitimate product

• Either party will notify the other within <<FILL: number>> hours of discovery of any product suspected to be counterfeit, falsified, diverted, or otherwise illegitimate.
• The party discovering the suspect product will quarantine it and will not return it to saleable stock, further distribution, or destruction pending joint investigation and, where required, notification to the relevant competent authority.

7. Temperature excursion notification and disposition

• Party 2 will notify Party 1 of any temperature or storage-condition excursion affecting Party 1’s product within <<FILL: number>> hours of discovery, and will quarantine the affected stock.
• Final disposition of excursed stock remains Party 1’s decision unless otherwise stated in a product-specific annex; Party 2 does not self-disposition.

8. Returns

• Party 2 will accept a return to saleable stock only when in-range storage is demonstrable for the entire time the unit was outside controlled conditions, packaging is intact, the product is in date, and the product identifier is verifiable; unmonitored returns default to non-saleable.
• Party 2 will notify Party 1 of any return pattern that suggests a systemic storage, handling, or diversion issue.

9. Recall and field action cooperation

• Party 2 will execute a recall or field action to its own downstream consignees within <<FILL: number>> hours of notification from Party 1, and will provide shipped-versus-retrieved reconciliation data within <<FILL: number>> business days of request.
• Party 2 will participate in a mock recall exercise on request, at a frequency of no less than <<FILL: e.g. annually>>.

10. Complaints

• A complaint received by either party that implicates the other party’s product, process, or the relationship between them will be forwarded within <<FILL: number>> business days.

11. Right to audit

• Each party has the right to audit the other’s facilities, systems, and records relevant to this agreement, on a routine schedule (<<FILL: frequency>>) and for cause, with <<FILL: notice period, or "no notice required for cause">>.
• Where direct facility access is not practicable (for example, a wholesale distributor auditing an upstream manufacturer, or vice versa across jurisdictions), the audited party will provide documentary evidence sufficient to demonstrate compliance with this agreement.

12. Change notification and reassessment

• Either party will notify the other within <<FILL: number>> business days of a change to its named RP, a change to its licensed storage sites, or a material change in ownership or license status.
• The parties will reassess this agreement and the underlying qualification at an interval of <<FILL: e.g. every 24 months>> or sooner for cause.

13. Term, termination, and record transfer

• This agreement remains in effect for <<FILL>> and may be terminated by either party with <<FILL: notice period>> written notice.
• On termination, Party 2 will retain and, on request, provide access to records generated under this agreement for the retention period stated in <<FILL: reference the applicable records retention requirement>>.

Acceptance criteria for this agreement

• Every clause carries a filled, specific value; no clause is left as a placeholder in the executed version.
• Named RPs (or equivalents) are current and match each party’s license record.
• Notification timeframes in sections 6 and 7 are short enough that a timely quality decision is possible.
• Legal and regulatory affairs have reviewed and countersigned before execution.

References

EU Guidelines on Good Distribution Practice (2013/C 343/01), Chapter 7 (Outsourced activities). Directive 2001/83/EC, Article 80 (wholesale distributor obligations). Delegated Regulation (EU) 2016/161 (unique identifier and safety features). Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act 2013).

Confirm the current version and clause numbers of each reference before issue.

Approvals

Filled specimen

Key clauses completed for an illustrative manufacturer-to-wholesale-distributor relationship.

The section 6 and section 7 clauses are what actually give Party 1 a contractual basis to demand fast notification and to hold disposition authority, terms a generic commercial supply contract would not have specified on its own.

Common inspection findings this agreement prevents

• A supply relationship with a wholesale distributor and no written quality agreement at all, discovered only when an excursion or complaint needs a decision.
• No named RP identified on either side, so an excursion or suspect-product event has no clear point of contact.
• No stated recall-execution timeframe for the wholesale distributor’s downstream consignees, so a recall’s reach cannot be demonstrated.
• Serialization obligations left implicit, so neither party can show who was responsible for a verification or decommissioning step.

How to adapt this agreement

1. Set the notification timeframes in sections 6, 7, and 9 against how quickly your team needs to act, not against what is administratively convenient for the counterparty.
2. Pair this agreement with the wholesale distributor GDP qualification checklist as the qualification evidence behind section 3 and section 11.
3. Where the relationship also involves contracted logistics execution (the wholesale distributor also warehouses on your behalf), consider whether the 3PL data integrity quality agreement addendum should also apply to that portion of the relationship.
4. Route through legal and regulatory affairs before execution; this template states quality obligations, not indemnification, pricing, or other commercial terms.