Emprove® Chemicals
For drug manufacturers striving to simplify raw material selection while satisfying regulatory requirements, our Emprove® Chemicals portfolio contains over 400 pharmaceutical raw materials organized by different levels of risk.
All raw and starting materials are organized into categories to streamline selection, with each product offering the comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
The portfolio is divided into four categories:
- Emprove® Evolve is for early stages of biopharmaceutical manufacturing, bridging the gap between lab-grade and GMP compliant raw and starting materials while providing transparent supply chain information and documentation.
- Emprove® Essential is for moderate-risk applications, offering compliance to IPEC-PQG GMP Guide and/or EXCiPACT™ Certification Standard, as well as supply chain transparency and regulatory support designed to assist drug manufacturers’ formalized risk assessments.
- Emprove® Expert is for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance. Along with the risk management features of Emprove® Essential, the Emprove® Expert line yields products with specified low microbiological and endotoxin levels, supporting the overall risk mitigation strategy.
- Emprove® API is for final drug product compliance with international standards, manufactured in Europe to meet the quality and regulatory requirements of active pharmaceutical ingredients (API) according to ICH Q7 GMP. Dedicated support by our regulatory management team includes access to extensive documentation, such as DMFs, CEP, and ASMF.
Keeping up with evolving regulations of raw materials
Critical raw materials used during production processes have no clearly defined regulatory standards or quality requirements, but are coming more and more into regulatory focus. We continue to advance our Emprove® Chemicals portfolio with the recent addition of the Emprove® Evolve product line, providing fit-for-purpose high-quality raw materials for early stage manufacturing applications. As developing regulatory requirements for critical raw materials pose new challenges, we will continue to evolve our offerings to support your quality risk assessment with detailed documentation and supply chain transparency and control.
Documentation to speed your way through the regulatory maze
As part of the Emprove® Program, the complete Emprove® Evolve, Essential, and Expert chemicals portfolio is supported by Emprove® Dossiers. This comprehensive documentation facilitates your qualification, risk assessment, and process optimization efforts.
Emprove® Dossier Library for Raw and Starting Materials
Material Qualification Dossier
Supports raw material qualification and speeds up drug filing preparation
In line with ICH CTD chapter 3 quality (adapted for excipients)
- General information
- Manufacture
- Characterization
- Elemental impurities (ICH Q3D)
- Control of drug substance
- Reference standard
- Container closure system including “Primary Packaging Material Statement”
- Stability
- Environmental Statement
Free of charge*
*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.
Quality Management Dossier
Answers questions during quality risk assessment according to ICH Q9 and EU 2015/C95/02.
- Supply chain information
- General GDP Statement
- Product Quality Self Assessment**
- Site Quality Self Assessment
- Audit report summary
- Risk Management Statement
- Change Management Statement
- Data integrity statement
Free of Charge*
*The Quality Management 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.
**Based on Rx-360 SAQ Module 3
Operational Excellence Dossier
Supports process optimization and safety risk assessment activities.
- Product quality report
- Stability data**
- Analytical procedure
- TUPP (if applicable)
- Extended Nitrite Information
Premium*
*The Operational Excellence Dossier can be purchased individually on the product detail pages of our website after log-in or unlimited access through our Emprove® Suite Subscription
**Available for Emprove® Essential and Emprove® Expert products only, based on long-term stability studies according to ICH Q1A requirements.
Emprove® API products come with the Emprove® API Information Package which supports API qualification and risk assessment. It includes:
- General Information
- Manufacture
- Specification
- Regulatory Certificates
- Product Quality Self Assessment
- Packaging Information
- Stability Summary and Conclusion
Quality and service transparency
We support our partners in their risk assessment efforts by providing detailed information about the applied Quality Management system, the supply chain, extractable data, and data on the stability of a product. To learn more, select any of the criteria below for our Quality & Service Catalog.
Emprove® Raw and Starting Materials by Category
Quality
Supply Chain
Manufacturing
Certificates
Specifications
THE NEW EMPROVE® SUITE: SPEED THROUGH COMPLEXITY WITH CONFIDENCE
Compliance with current Good Manufacturing Practices is a continuum. Changes are inevitable. Audits and periodic reviews are necessary.
Take a seat: The Emprove® Suite is here to improve your risk assessment journey. This Information-as-a-Service digital platform is your co-pilot to support your need for convenient access to reliable information – anywhere, anytime. A subscription helps you stay current: You can not only easily find, view and download Emprove® Dossiers, but also to “opt-in” to notification updates to be informed of changes to documents. You can also generate Emprove® Dossier download metrics and reports, and so much more.
Ultimately, a subscription to the Emprove® Suite empowers you to:
- take advantage of everything the Emprove® Program has to offer
- collaborate and share information globally
- speed your way through the complexity of compliance with confidence
Related Resources
- Article: Managing Nitrite Impurities: A Supplier-Manufacturer Approach to Mitigating Nitrosamine Risk
Given the safety risk of nitrosamines, drug product manufacturers must assess their level in pharmaceutical products and define mitigation actions. This page describes how nitrosamines are formed, the prevalence in pharmaceuticals, quantitation methods, and strategies for managing nitrite impurities.
- Brochure: Satisfy your regulatory requirements
Transparency and comprehensive documentation with the Emprove® Program.
- Risk Mitigation Tool: Support for Biomanufacturing Processes
This interactive tool guides you through the challenges and quality requirements of your bio-manufacturing process.
- White Paper: Identifying Appropriate-quality Raw Materials in an Evolving Regulatory Environment
This document is effectively the first industry ”how-to‟ translation of the various regulations relevant to qualification of raw materials.
- Article: Successfully Navigate the Regulatory Landscape for Chemicals and Single-Use Consumables
Get an overview of terminology and key considerations related to regulatory expectations for chemical raw materials and qualification of components and single-use assemblies including extractable and leachable testing.
Related Videos
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