Three Levels of Information for Material Qualification, Risk Assessment and Process Optimization
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- 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
*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
||Free of charge*
- General information
- Manufacturing flow chart
- Product validation and qualification
- Specifications (design and release criteria)
- Materials of construction
- Extractables summary**
- Regulatory statements (Animal origin, e.g. Animal Origin, BPA etc.)
|Quality Management Dossier
||Answers questions during risk assessment
- Quality Self-assessments
- Chain of custody
- Supplier and CMO management
- Shelf life testing and results
- Packaging and Sterilization Validation
|Operational Excellence Dossier
||Supports process optimization
- Extractables Report**
- Elemental impurities summary
- Analytical procedure
|Subscribe to Emprove® Suite
||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
**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.