Purpose and scope The purpose of this document is to describe the essential quality requirements for written contractual agreements for work to be contracted out under GP- or GMP-requirements. This module covers only the QA part of the contract. It applies to all Healthcare sectors.
Responsibilities The Contract Giver is responsible to establish the QA part of the contract agreement.
Requirements A potential Contract Acceptor must have a licence for the work to be performed.
Prior to any contract agreement signature for work that falls under GP- or GMP -requirements, the Contract Giver and the relevant QA must determine the ability of the Contract Acceptor to satisfy the quality requirements (compliance with the required GP and sanofi-aventis standards). This is normally done by an audit of the facilities, but may be based on documented evidence from previous collaborations and other contracts.
Contracts for GMP work to be used in Phase 3 or later and for all manufacturing of sterile products must be based on an audit. An audit report must be available prior to signing a contract.
This audit is to be performed by the QA unit of the Contract Giver and/or CQA. They make recommendations to management on acceptability for contract work this is based on the review of the findings of the audit and the corrective action plan (if needed) submitted by the Contract Acceptor.
All technical documentation needed to perform the work to be contracted out shall be handed over to the Contract Acceptor.
The contract agreement must specify
The contract should cover all technical agreements and must be agreed and signed by all parties prior to commencement of any activity.
