Follow
1 Principle. Contract production and analysis must be properly defined, agreed and controlled to avoid misunderstandings that could result in product or work or analysis of unsatisfactory quality.
general
2 All measures for contract manufacturing and analysis, including any proposed changes in technical or other measures, should be in accordance with the marketing authorization of the product concerned.
3 The contract shall allow the contract provider to audit the contract recipient’s facilities
4 In the case of contract analysis, final approval for release must be given by the authorized person.
Contract giver
5 The contractor is responsible for evaluating the contractor’s ability to successfully perform the tasks or tests, for approving the contract activities and for ensuring through the contract that the principles of GMP described in this guide are followed.
6 The Contract Acceptor shall provide the Contract Provider with all information necessary for the proper performance of the Contract activities in accordance with the marketing authorization and any other legal requirements. The contractor must ensure that the contractor is fully aware of any problems related to the product, work or tests that may pose a hazard to the premises, equipment, personnel, other materials or other products.
7 The contract provider shall ensure that all processed products and materials supplied by the contract recipient comply with their specifications or the product has been disclosed by the authorized person.
Contract acceptor
8 The Contractor must have adequate premises, equipment, knowledge and experience and suitable personnel to satisfactorily perform the work ordered by the Contractor. Contract manufacturing can only be done by a manufacturer who has a manufacturing authorization.
9 The Contractor shall not assign any work assigned to him or her under the Contract to a third party without prior evaluation and arrangement approval by the Contractor. Arrangements made between the contractor and the third party must ensure that production and analytical information is made available equally between the original contractor and the contractor.
10 The contract recipient shall refrain from any activity that may adversely affect the quality of products produced and/or analyzed for the contract provider.
The contract
11 There must be a written agreement between the contractor and the contractor that clearly establishes the responsibilities of each party
12 The contract must clearly state that the authorized person, when releasing each batch of product for sale or issuing a certificate of analysis, exercises his full responsibility and ensures that each batch is manufactured and tested for compliance. including marketing authorization requirements.
13 Technical aspects of the contract should be developed by persons suitably knowledgeable in pharmaceutical technology, analysis and GMP.
14 All arrangements for manufacture and analysis must be in accordance with the marketing authorization and agreed upon by both parties.
15 The contract should clearly describe who is responsible for purchasing, testing and releasing materials and for manufacturing and quality control, including in-process controls and who is responsible for sampling and analysis. In the case of contract analysis, the contract should specify whether the contractor must take samples at the manufacturer’s premises.
16 Manufacturing, analytical, distribution records and reference samples should be maintained or obtained from the contractor. Any records relevant to product quality assessment in case of complaints or suspected defects must be accessible and referred to in the contractor’s defect/withdrawal procedure.
17 The contract should describe the handling of starting materials, intermediate feed and bulk products and finished products if rejected. If the contract analysis shows that the tested product must be rejected, it should describe the procedure to be followed.
