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DURAN® PURE — QUALIFICATION DOCUMENTATION AVAILABLE ONLINE DURAN PURE bottles and closures meet the requirements of the national and international pharmacopoeias, and are supported by a full range of documents and certifications that meet the detailed requirements of the regulatory authorities. A comprehensive qualification package providing product information and supplier qualification is available for download from www.duran-group.com.
Qualification and Validation includes:
DURAN PURE Bottle/Premium Screw Cap
Certificate of conformity DURAN®
Certificate of conformity USP Class VI
Product specification
Technical drawing
Material Safety Data Sheet (MSDS)
REACH compliance certificate
Certificate of food contact safety
BSE/TSE/GMO certification
Certificate of heavy metal content
Lot certificate
Certificate of Analysis (CoA) Qualification documentation
Auditing capability
Supplier questionnaire
Drug Master File (DMF), Type III
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