Purpose and scope For manufacturing and testing by third parties a written contract has to be established which regulates the duties and responsibilities of each partner.
This module is valid for all contracts with regard to third party manufacturing, packaging, storage and distribution, testing, and release of active substances, bulk materials, finished drug products on behalf of (---) sectors. It does not consider other types of legal contracts, such as supply agreements, service contracts, licence contracts etc.
Responsibilities The management of each Healthcare Sector Company (Contract Giver) has to implement a QA-system which will assure that no manufacturing, packaging, storage, testing or release orders are transferred to a third party (Contract Acceptor) without a valid contract.
It must be assured that all necessary technical information is supplied to the third party that he is able to perform the order and the product specific requirements.
The Contract Giver is responsible to assure compliance with the product licenses handed over to the Health Authorities.
The local QA Head/Authorised Person is responsible to evaluate the competence of third parties for the intended purpose and to prove compliance with GMPs.
The organisation of the third party (Contract Acceptor) is responsible to assure that all details of the contract are fulfilled in accordance of the current state of the art.
Requirements All agreed arrangements regarding the outsourced work must be fixed in a written contract.
Duties and responsibilities of all persons and departments involved from both parties must be described in the contract, such as
The contract has to be signed prior to application by the responsible manager of both parties.
