IntroductionThe Emprove® dossiers a

IntroductionThe Emprove® dossiers are designed to enable our customers to respond to the regulatoryrecommendations/requirements easily, quickly, and adequately. As a result of the Emprove®qualification processes, we offer the Emprove® Material Qualification Dossier (in line with CTD format).This dossier is designed to facilitate qualification of material for application in the pharmaceuticalindustry. With the Emprove® Quality Management Dossier, we assist in conducting the required riskassessments. With the Emprove® Operational Excellence Dossier, we provide supporting informationto optimize processes according to the relevant regulations.Version historyThe dossier version number is indicated in the header of every page. Product quality-relevant contentchanges result in a full-version increase, for example version 1.0 to 2.0. Editorial or formattingchanges result in a sub-version increase, for example 1.0 to 1.1.Additionally, the Version History Report provides an overview of components which have beenupdated in this version.Regulatory FrameworkMarketing Authorization Holders are responsible for qualifying the raw and starting materials used intheir products and assessing the risk associated with their use. To facilitate qualification and the firststeps of the required risk assessment required by EU Guideline 2015/C 95/02, we provide a set ofquality and regulatory documentation free of charge in our Material Qualification Dossier, providingevidence e.g. for adherence to The Joint IPEC-PQG Good Manufacturing Guide for PharmaceuticalExcipients as well as the EXCiPACT™ Standard, where applicable.The dossier content includes information on applied quality systems, manufacturing processes,product characterization, regulatory certificates and more.