The Contract (1)
Written: Defining each party’s responsibilities
Technical aspects drawn up by competent persons with knowledge in pharmaceutical technology, analysis and GMP
Batch release/COA issued by the authorized person, compliance with marketing authorization
Production and analysis arrangements as in marketing authorization - agreed to by both parties
Describe handling of rejected materials
The contract that is prepared between the contract giver and the contract accepter must identify clearly the responsibilities each has with respect to the relevant sections, and the work to be done. All the technical details and specifications must be prepared by competent technical staff. All the arrangements must be in accordance with the marketing authorizations and agreed by both giver and accepter.
The contract must be very clear about the way in which the authorized person will approve the product for sale. It must enable the authorized person to check that each batch has been made in compliance with the marketing authorization.
The contract must specify who is responsible for the purchase and testing of all incoming materials and their release to production. It must also specify all the in-process testing that is to be done and who is responsible for sampling and analysis. In the case of contract analysis, the contract should specify whether the contract accepter is responsible for sampling, and if so where the sampling is to be done. If contract analysis is being undertaken then the contract must show how the information will be processed and in what time span it will be done.