This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers.The root of many of the problems lies in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files) which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.
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