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Emprove® Program

 

Explore Transparency

The Emprove® Program provides full supplier transparency at your fingertips, anticipating industry expectations not yet covered by regulation. Find comprehensive regulatory documentation for filters, single-use components and raw and starting materials to simplify your qualification, risk assessment and process optimization.

It helps you meet the latest regulatory requirements by:

 

 

Emprove® Portfolio

Our Emprove® portfolio spans products from approximately 400 chemicals to various filtration and single use devices and components.

 

Emprove® Dossiers

To support you throughout different stages of your operations: qualification, risk assessment, and optimization we have created three different types of dossiers.

The three types of Emprove® Dossiers which support you throughout the different stages of your operations are:

Material Qualification Dossier – Information to start material qualification.
Quality Management Dossier – Answers questions during risk assessment.
Operational Excellence Dossier – Supports process optimization.

 

Glance of Emprove® Chemicals quality attributes:

 
Product Quality Attributes Emprove® Evolve Emprove® Essential & Emprove® Expert
Regulatory
  • Non-GMP: Manufactured utilizing GMP concepts and elements; ISO9001 or equivalent
  • Supply chain transparency and control
  • No defined industry standards or regulations
  • Non-compendial; not for direct human use
  • GMP: IPEC/EXCiPACT™ plus elements of ICH
  • Defined regulations and GMP standards
  • Compendial compliance; intended as suitable for human use
Examples of use/Application
(Examples only: customers’ responsibility to assess and decide on appropriate quality of raw materials for their use)
  • Process chemicals & clean-in-place
  • Upstream, early downstream, early synthetic steps
  • Higher risk applications, close to final drug product & patient
  • Formulation, late downstream & purification
Product shelf-life/stability
  • Shelf-life based on analysis of 3 batches/historical data/retests
  • Summary statement in Emprove® dossier
  • Long-term stability studies according to ICH Q1A requirements
  • Detailed stability study data in Emprove® dossier
Supplier qualification
  • High
  • Paper assessment mandatory
  • On-site audit preferred; exceptions possible under certain conditions
  • Change agreement
  • High
  • On-site audit mandatory
  • Quality/change agreement
Change control
  • High
  • High

 

Learn more about our SAFC PharmaGrade™ Portfolio integration into the Emprove® Program

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Subscribe to the Emprove® Suite

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. It provides online access to all dossiers of the entire Emprove® portfolio for 1,2 or 5 years.

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