The Material Qualification Dossier supports product qualification and speeds up regulatory filing preparation. It includes content on the manufacturing process, product specifications and various qualification criteria (product validation data), regulatory statements, and more.
The Quality Management Dossier supports your risk assessment needs through useful information on how quality variability attributes are controlled, such as site quality self-assessments, product family shelf life information, sterilization and product packaging validation.
The Operational Excellence Dossier supports process optimization objectives. It contains extractables profiles aligned with industry standardized practices such as the BPOG's standardized extractables testing protocol for single-use systems in biomanufacturing and USP general chapter <665>. It also includes information on elemental impurities (ICH Q3D) that can be utilized to perform extractables and leachables (E&L) risk assessment for the product. The test methodology in the Operational Excellence Dossier involves a “worst case” approach.
For filters, the dossiers are grouped according to product families with the same materials of construction, production processes, and packaging components. The test methodology in the Operational Excellence Dossier involves a “worst case” approach.
For single-use components, dossiers are made available for components starting with those most commonly used. An assembly level information can be developed from the individual dossiers available for the components forming the part of the single-use assembly.
How Emprove® Dossiers for Filters and Single-use Components can support you
Emprove® Dossier Library for Filtration and Single-use
Purpose of Dossier
Material Qualification Dossier
Information to start a material qualification
Free of charge*
Manufacturing flow chart
Product validation and qualification
Specifications (design and release criteria)
Materials of construction
Regulatory statements (Animal origin, e.g. Animal Origin, BPA etc.)
Full Access to All Dossiers of the Emprove® Library
10.000€, 20.000€, 45.000€
One time registration
Access for 1, 2 or 5 years
Includes 5 email addresses per company
Additional accesses can be purchased
*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. **Standardized Extractables Protocol, BPOG, published in Pharmaceutical Engineering 11.2014 & USP draft chapter <665>, published 05.2017.
To learn more about our Emprove® Dossiers for raw and starting materials please click here.