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Technical Agreements for Outsourced Activities in GDP

Technical Agreements for Outsourced Activities in GDP

Chapter 7 of the EU Guidelines 2013/C 343/01 refers to the outsourcing of Good Distribution Practice activities to third party providers:

Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party.

The written contract mentioned in the clause is usually referred to as a technical or quality agreement and outlines the responsibilities of both parties i.e. the contract giver and the contract acceptor.

The contract giver is responsible for the activities outsourced and a technical agreement ensures the contract acceptor complies with GDP principles.

GDP Technical Agreements vs Commercial Agreements

The technical agreement does not cover any commercial terms between the two legal entities. These should be covered in a separate commercial agreement between the contract giver and contract acceptor.

GDP technical agreements are usually written by an expert who specialises in GDP principles and commercial agreements are written be the company’s legal department.

It is important to ensure the two agreements to refer to each other and care should be taken to avoid any anomalies between the two documents as this could be challenging in the event of a dispute.

Contents of a GDP Technical Agreement

Clauses included in a technical agreement covering GDP principles will depend on the activity being outsourced.

For instance a GDP technical agreement between a WDA (H) holder and a contract warehouse may include the following details:

  • Scope and Purpose
  • Personnel (contract giver and contract acceptor)
  • Goods Received
  • Storage Conditions
  • Temperature Monitoring
  • Stock Control
  • Sales Order Procedure
  • Picking and Packing
  • Batch Control
  • Delivery of Parcels and Pallets
  • Product and Distribution Complaints
  • Returns and Recalls
  • Product Quarantine
  • Product Disposal
  • GDP Audit
  • Self-Inspection
  • CAPA Procedure
  • Documentation Retention
  • Pest Control
  • Security
  • Health and Safety
  • Exceptional Activities
  • Dispute Resolution Procedure
  • Contact Details
  • Change Control
  • Responsibilities Matrix for both Contract Giver and Contract Acceptor

Are your GDP technical agreements robust enough?

Are your GDP technical agreements congruent with the commercial agreements in place? If not you are at serious risk if there is a dispute.

If you require assistance in constructing a robust GDP technical agreement please then contact Pharma Experts.

About the Author:

Zul Mamon
Zul is a Senior Consultant, Pharmacist, ISO 9001 Lead Auditor and GDP Trainer. He has extensive experience in the pharmaceutical sector, having worked for both the independent and national multisite organisations.

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