How Emprove® Dossiers for Chemicals support you
Three Levels of Information for Raw and Starting Materials
To address evolving regulatory requirements, we are constantly developing our Emprove® dossier library to better meet your challenges. The information on our Emprove® Essential and Emprove® Expert products is organized into three types of dossiers. Each dossier’s name indicates where it can be used to facilitate your qualification, risk assessment and process optimization efforts.
- The Material Qualification Dossier supports qualification and speeds up drug filing preparation. It includes content on manufacturing processes, characterizations, certificates, justification, stability summary, and more.
- The Quality Management Dossier supports risk assessment according to ICH Q9 and EU 2015/C95/02 by offering extended information on the supply chain and Quality Management System as well as stability data.
- The Operational Excellence Dossier supports process optimization activities around Elemental Impurities (ICH Q3D), Product Quality Reports, and Analytical Procedures.
Emprove® Dossier Library for Raw and Starting Materials
*The Material Qualification Dossier is free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.
|Dossier Name||Purpose of Dossier||Price||Content|
|Material Qualification Dossier
||Information to start a material qualification
In line with CTD chapter 3 quality (adapted for excipients)
|Free of charge*
- General information
- Control of drug substance
- Reference standard
- Container closure system
- Stability summary
|Quality Management Dossier
|Answers questions during risk assessment
- Product quality self-assessment
- Audit report summary
- Supply chain information
- Stability data
|Operational Excellence Dossier
|Supports process optimization
- Product quality report
- Elemental impurity information
- Analytical procedure
|Subscribe to Emprove® Suite
||Full Access to all dossiers of the Emprove® Library
- One time registration
- Includes 5 email addresses per company
- Access for 2 years
- Additional accesses can be purchased
To learn more about our dossiers for filters and single-use components please click here