Contract acceptor

ICH Q10 (2007) stated that the responsibilities of quality systems extend to the oversight and review of outsourced activities, stating that the contract giver should be responsible for assessing the suitability and competence of the contract acceptor to carry out the work required . 

And further, that the responsibilities for quality-related activities of the contract giver and contract acceptor should be specified in a written agreement . Similarly, ISO 9001 (2000) states that, Where an organization chooses to outsource any process that affects product conformity, the organisation shall ensure control over such outsourced processes. Control of such outsourced processes shall be identified within the quality management system. ... 

The supplier of pharmaceutical products should, prior to the dispatch of such products, ensure that the person or entity, e.g. the contract acceptor for transportation of the pharmaceutical products, is aware of and complies with the appropriate storage and transport conditions. 

Procurement agencies are ultimately responsible for the outcomes of all four key activities. In some cases, one or more of the activities may be contracted out. Where this occurs, a written contract which describes the responsibilities of both parties should be agreed upon between the two parties. The contract-giver remains responsible for ensuring that the contract-acceptor meets the norms and standards reflected in this Model. Recommendations... 

A laboratory may be contracted to perform the analyses. In that case, the procurement agency should ensure that the laboratory complies with GMP and good practices for control laboratories (10). The use of an accredited laboratory is therefore recommended. The procurement agency should verify the accreditation. There should be a written contract or agreement between the procurement agency and the contract laboratory. The wording of the contract should be clear and it should specify the responsibilities of the contract-giver and the contract-acceptor. 

The procurement agency (contract-giver) may decide to contract the services of an agency (contract-acceptor) with expertise in technical assessment of product data and information and/or inspection of manufacturing facilities. However, the contract-giver remains responsible for the implementation and monitoring of these activities. 

Periodic review of the contract should be based on an assessment of the contractor s overall performance. The criteria outlined for monitoring of prequalified products and manufacturers (see Section III. 6) also apply to monitoring of contract-acceptors who store and distribute pharmaceutical products. 

Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The contract must clearly state the way in which the authorised person releasing each batch of product for sale exercises his full responsibility. 

NOTE This Chapter deals with the responsibilities of manufacturers towards the Competent Authorities of the Member States with respect to the granting of marketing and manufacturing authorizations. It is not intended in any way to affect the respective liability of contract acceptors and contract givers to consumers. 

The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required and for ensuring by means of the contract that the principles and Guidelines of GMP as interpreted in this Guide are followed. 

The Contract Giver should provide the Contract Acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authorization and any other legal requirements. The Contract Giver should ensure that the Contract Acceptor is fully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other products. 

The Contract Giver should ensure that all processed products and materials delivered to him by the Contract Acceptor comply with their specifications or that the products have been released by an authorised person. 

The Contract Acceptor must have adequate premises and equipment, knowledge and experience, and competent personnel to... 

The Contract Acceptor should ensure that ail products or materials delivered to him are suitable for their intended purpose. 

The Contract Acceptor should not pass to a third party any of the work entrusted to him under the contract without the Contract Giver s prior evaluation and approval of the arrangements. Arrangements made between the Contract Acceptor and any third party should ensure that the manufacturing and analytical information is made available in the same way as between the original Contract Giver and Contract Acceptor. 

The Contract Acceptor should refrain from any activity which may adversely affect the quality of the product manufactured and/or analysed for the Contract Giver. 

The contract should describe clearly who is responsible for purchasing materials, testing and releasing materials, undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis. In the case of contract analysis, the contract should state whether or not the Contract Acceptor should take samples at the premises of the manufacturer. 

The contract should permit the Contract Giver to visit the facilities of the Contract Acceptor. 

In the case of contract analysis, the Contract Acceptor should understand that he is subject to inspection by the competent Authorities. 

The Contract Acceptor must have adequate premises and equipment, knowledge and experience, and competent personnel to carry out satisfactorily the work ordered by the Contract Giver. Contract manufacture may be undertaken only by a manufacturer who is the holder of a manufacturing authorisation. 

Contract Acceptor should take samples at the premises of the manufacturer. 

The Contract Giver should ascertain that where a license is required forthe class of goods and operations being contracted, the Contract Acceptor is appropriately licensed. 

The Contract Giver should also be satisfied that the Contract Acceptor has the capability to do the work and that the operations can be carried out in the agreed manner... 

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