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Emprove® Dossier Library

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All our subscribers to the Emprove® Suite get online access to all dossiers of the entire Emprove® portfolio for two years.

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Our three different types of dossiers support you throughout the different stages of your operations: material qualification, quality risk assessment, process optimization, and safety risk assessment. Find the right information for your needs.
Raw and Starting Materials
Material Qualification Dossier
Information to start a material qualification
Quality Management Dossier
Answers questions during quality risk assessment
Operational Excellence Dossier
Supports process optimization and safety risk assessment
  • General Information
  • Manufacturing Flow Chart
  • Characterization
  • Control of drug substance
  • Reference standard
  • Materials
  • Container closure systems
  • Stability
  • Quality self-assessment
  • Audit report summary
  • Supply chain information
  • Stability data*
  • Product quality report
  • Elemental impurity information
  • Analytical procedure
  • Technically Unavoidable Particle Profiles (if applicable)
Filtration and Single-Use
Material Qualification Dossier
Information to start a material qualification
Quality Management Dossier
Answers questions during quality risk assessment
Operational Excellence Dossier
Supports process optimization and safety risk assessment
  • General Information
  • Manufacturing flow chart
  • Product validation and qualification
  • Specifications (design and release criteria)
  • Materials of construction
  • Extractables summary**
  • Regulatory statements (e.g. Animal origin, BPA etc.)
  • Quality Self-assessment
  • Supplier and CMO management
  • Chain of custody
  • Shelf life testing and results
  • Packaging and Sterilization Validation
  • Extractables Report**
  • Elemental impurities Information
  • Analytical procedure

* Available for Emprove® Essential and Emprove® Expert products only.

** Standardized Extractables Protocol, BPOG, published in Pharmaceutical Engineering 11.2014 & USP draft chapter <665>, published 03.2019