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Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products
V1.0, April 2013
- Subcontracting should be correctly defined, agreed and controlled in order to avoid misunderstandings, which could result in a product or work of unsatisfactory quality. There should be a written agreement between the manufacturer and the subcontractor, which clearly establishes the duties of each party.
- The subcontractor (e.g. testing, irradiation, pest control, cleaning, calibration, preventive maintenance) should be subject to an initial evaluation and regular review to ensure compliance with the quality system. Subcontracting should be covered by a formal documented agreement specifying the responsibilities of both parties. If applicable, subcontracted personnel should be trained in GMP or supervised whilst on the licensed premises. Records should be maintained.
- The contract acceptor must not subcontract any work without written authorisation from the contract giver.