Verträge im GMP-Umfeld Teil 1 Dr. Falk Klar Biomeva GmbH, Heidelberg The unambiguous allocation of the responsibilities is of pivotal importance in the GMP area. Inside of a company working groups, departments or sites have to comply with this request. In case different suppliers contribute to a product or a process, responsibilities have to be allocated beyond a company. This applies if raw materials, disposables, equipment or other materials for GMP purposes are purchased from external suppliers in a supply chain. Likewise this applies for external vendors contributing with services to GMP activities. This could be test laboratories, calibration contractors or cleaning vendors. Contracts could be used for determination of responsibilities between different companies. Several types of contracts have been developed, which will be introduced by their core contents. The interlinking of those contract types is explained. Advice for structuring of contracts is given. Most important legal aspects to be observed during generation and implementation of contracts are covered. Furthermore, requirements arising from international contracts are discussed. |
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pharmind 2010, Nr. 4, Seite 626
