Contract giver

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. ... 

Any activity relating to the distribution of a pharmaceutical product which is delegated to another person or entity should be performed according to the terms of a written contract which is agreed upon by the contract giver and the contract accepter. 

Subcontracting may be permissible under certain conditions subject to the written approval of the contract giver. 

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. 

CONTRACT PRODUCTION AND ANALYSIS Principle. Contract production and analysis must be correctly defined, agreed, and controlled in order to avoid misunderstandings that could result in a product or work or analysis of unsatisfactory quality. There must be a written contract between the contract giver and the contract accepter which dearly establishes the duties of each party. The contract must dearly state the way in which the authorized person, in releasing each batch of product for sale or issuing the certificate of analysis, exercises his or her full responsibility. 

There should be a written contract covering the manufacture and/or analyse arranged under contract and any technical arrangements made in connection with it The contract should permit the contract giver to audit the facilities of the contract accepter. 

The contract giver is responsible for assessing the competence of the contract accepter in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of GMP described in this guide are followed. 

The contract giver should provide the contract accepter with ail 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 accepter is fully aware of any problems associated with the product, work, or tests that might pose a hazard to premises, equipment, personnel, other materials, or other products. 

The contract giver should ensure that all processed... 

The contract accepter must have adequate premises, 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 holds a manufacturing authorization. 

The contract accepter should not pass to a third party any of the work entrusted to him or her under the contract without the contract giver s prior evaluation and approval of the arrangements. Arrangements made between the contract accepter 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 accepter. 

The contract accepter should refrain from any activity that may adversely affect the quality of the product manufactured and/or analysed for the contract giver. 

A contract should be drawn up between the contract giver and the contract accepter that specifies their respective responsibilities relating to the manufacture and control of the product Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and GMP. All arrangements for production and analysis must be in accordance with the marketing authorization and agreed by both parties. 

Manufacturing, analytical, and distribution records and reference samples should be kept by, or be available to, the contract giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect must be accessible and specified in the defed/recall procedures of the contract giver. 

The contract should permit the contract giver to audit the facilities of the contract accepter. 

The contract giver should ensure that all processed products and materials delivered by the contract accepter comply with their specifications or that the product has been released by the authorized person(s). 

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. 

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