Emprove® Dossier Library

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The innovative Emprove® Program has been providing efficient regulatory documentation to the pharma and biopharma industry for over a decade, even as the number of regulations has tremendously increased.

With the Emprove® Program, we address tomorrow’s regulatory questions today. Three different types of dossiers will support you throughout the different stages of your operations: qualification, risk assessment, and process optimization.

Raw and Starting Materials
Material Qualification Dossier
Information to start a material qualification
Quality Management Dossier
Answers questions during risk assessment
Operational Excellence Dossier
Supports process optimization
  • General Information
  • Manufacturing flow chart
  • Product characterization and qualification
  • Control of drug substance
  • Reference standard
  • Materials
  • Container closure systems
  • Stability summary
  • Product quality self-assessment
  • Audit report summary
  • Supply chain information
  • Stability data
  • Product quality report
  • Elemental impurity information
  • Analytical procedure
Filtration and Single-Use
Material Qualification Dossier
Information to start a material qualification
Quality Management Dossier
Answers questions during risk assessment
Operational Excellence Dossier
Supports process optimization
  • General Information
  • Manufacturing flow chart
  • Product characterization and qualification
  • Specification, release criteria
  • Materials of construction
  • Extractables summary*
  • Residual solvents statement
  • Regulatory statements (Animal origin, allergens ... )
  • Quality self assessment
  • Supplier and CMO management
  • Shelf life testing and results
  • Packaging and sterility validation
  • Extractables report*
  • Elemental impurity information
  • Analytical procedure

* Standardized Extractables Protocol, BPOG, published in Pharmaceutical Engineering 11.2014 & USP draft chapter <665>, published 05.2017.

Emprove Program

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Getting the relevant information is now more convenient than ever: in addition to buying single dossiers, you can use the new Emprove® Suite online to find all our Emprove® dossiers. The Suite is constantly updated and is optimized for targeted search. 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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