definiens: shall mean release of Finished Product(s ) to the market Manufacturing Documentation " consists of the description of manufacturing of Bulk Product(s ) including the in - process controls and processing instructions including the bill of materials describe the procedure of packaging and include the bill of materials for the packaging of the Bulk Product(s ) ; shall mean the written description of the sum of testing methods § 2 Subject - matter of the OM The subject - matter of this OM is to ensure that the manufacturing operations during the manufacture of the Bulk Product I Finished Product are carried out in accordance with the recognized pharmaceutical regulations and other regulations as well as requirements of the authorities, the requirements of the EC Directive 2003/94 / EC effective as of Nov. 2003, the requirements of the GMP guidelines, the EC GMP Guide and the GMP requirements of the US Food and Drug Administration ( FDA ) each in its current version in so far as these affect quality of the Bulk Product(s ) I Finished Product