委托s14035.pptVIP

---THE END--- World Health Organization * * The contract accepter also has responsibilities. The company must be competent to do the work. It means that it has the necessary facilities, premises and equipment, both in type and in quantity, to undertake the work. It must have a manufacturing authorization to do this type of work. This means that its staff has the necessary qualifications, training and experience to be able to do the work World Health Organization * * The contract accepter may not pass the work or any part of it on to a (third) subcontractor party without the approval of the contract giver. In order for the contract giver to be able to accept a third party, it must be able to undertake all the audits that it needs to be reassured that the third party is competent. All the responsibilities placed upon the contract accepter must be fulfilled by any third party contractor that may be employed. Finally, once a contract accepter has signed the contract, it must not then undertake new work which might adversely affect the quality of the existing products. An illustration of this would be to take on manufacture a penicillin product in the same facility, as other products of the contract giver. World Health Organization * * 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 materi