Emprove® Chemicals—Speeding up qualification and risk assessment
How can you confidently manage risks and comply with evolving pharma regulations?
Throughout the entire process, from upstream to final formulation, raw material quality and reliable accompanying documentation is essential to ensure process robustness and final drug product safety.
Explore how comprehensive, up-to-date documentation that’s easily accessible through the Emprove® Suite empowers you to confidently navigate regulations, manage risks, and optimize your workflows.
How can the Emprove® Chemicals portfolio improve your process?
Why spend time on cumbersome information gathering? The Emprove® Chemicals Portfolio comes with transparent, reliable information including recent additions like nitrosamine and lifecycle assessment data to enable faster decision-making, streamlined qualification, and improved efficiency.
More than 500 pharmaceutical raw materials and excipients classified according to risk level.
24/7 access to reliable information tailored to pharma raw material needs, including TUPPs, nitrite assessment, and more.
Ready-to-use data packages that support risk assessment, qualification, and regulatory requirements.
Risk-based classification to guide your raw materials selection
The Emprove® product line offers four quality levels—Emprove® Evolve, Emprove® Essential, Emprove® Expert, and Emprove® API—tailored to address different levels of risk, and to simplify the selection process.
- For early stages of biopharmaceutical manufacturing
- Fills the gap between lab-grade and GMP compliant process raw materials
- Quality and supply chain documentation to support risk assessments for non-GMP process chemicals
- For moderate risk applications
- Compliance to IPEC-PQG GMP Guide and/or EXCiPACT® Certification Standard
- Supply chain transparency, comprehensive documentation, and regulatory support to assist product qualification, formalized risk assessments, and process optimization efforts
- For high risk applications
- Compliance to IPEC-PQG GMP Guide and/or EXCiPACT® Certification Standard
- Lowest microbial and endotoxin levels for high-risk applications
- Supply chain transparency, comprehensive documentation, and regulatory support to assist product qualification, formalized risk assessments, and process optimization efforts
- For final drug product compliance with international standards
- Manufactured according to ICH Q7 GMP to meet the quality and regulatory requirements of active pharmaceutical ingredients (API)
- Comprehensive information to support API qualification and risk assessment efforts
- Dedicated support by our regulatory management team includes access to extensive documentation, such as API information package, DMFs, CEP, and ASMF
The Emprove® Chemicals quality levels are tailored to different process steps and application needs. Compare how the information provided differs for Emprove® Evolve, Emprove® Essential, Emprove® Expert, and Emprove® API raw materials, and identify which Emprove® Chemicals quality level best fits your application:
Do you want to know which information you’ll get with the Emprove® Dossier?
Industry-leading documentation and expertise
With more than a century of experience in pharma, a profound quality and regulatory expertise, and a commitment to innovation, we lead the way in anticipating and addressing emerging regulatory trends and requirements. Our documentation doesn’t just keep pace with current standards—it sets new benchmarks and is continuously evolving:
- Elemental impurity information became part of our Emprove® Dossiers while the ICH Q3D guidance was still in development.
- As of 2024, all Emprove® Essential, Expert, and API chemicals have been assessed for the presence of nitrite, supporting nitrosamine risk assessments.
- Most recently, we have incorporated life cycle assessment (LCA) information to meet evolving sustainability regulations.
This proactive approach ensures that our customers always have access to the most reliable, comprehensive, and future-proof information—empowering confident, compliant decision-making today and tomorrow.
Frequently asked questions
What is the Emprove® Chemicals Portfolio and how does it support risk assessment and regulatory approval?
The Emprove® Chemicals Portfolio provides a broad range of pharmaceutical raw materials, excipients, and active pharmaceutical ingredients with structured, up-to-date documentation tailored to different application needs. Having the technical, supply, regulatory, and quality information in Emprove® Dossiers easily accessible via our online repository Emprove® Suite helps reduce time and effort needed to compile information for risk assessment, qualification, and regulatory filings.
What documentation and regulatory support are provided in Emprove® Dossiers for chemicals and raw materials?
Emprove® Dossiers include information needed for material qualification and supplier qualification, information on impurities like technically unavoidable particles (TUP) or nitrites, and other insights. They are designed to streamline qualification, risk assessment, and regulatory submissions.
What challenges in biopharmaceutical manufacturing does Emprove® Evolve address?
Emprove® Evolve targets early-stage manufacturing needs, bridging the gap between lab-scale materials and GMP-compliant inputs. This quality level implements elements of GMP standards and is accompanied by documentation suitable for non-GMP process chemicals, including transparent quality, impurity, and supply chain information.
How are excipients categorized and which information is provided in Emprove® Dossiers?
Excipients are categorized into two different quality levels: Emprove® Essential and Emprove® Expert depending on the risk level and application. We recommend Emprove® Expert excipients for high-risk application such as parenteral formulations as they come with specified low endotoxin and microbial levels, while Emprove® Essential excipients are typically well suited for other, medium risk applications. Curious to learn more? Download Demo Dossier here.
Is life cycle assessment (LCA) information included in Emprove® Dossiers?
Yes, life cycle assessment information is incorporated where relevant, supporting both sustainability considerations and regulatory expectations for the material and its use in the manufacturing process. Learn more about LCA and how the Emprove® Program supports sustainability efforts.
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.
- Article: Building regional process liquids and buffers supply chains
See how a global-local manufacturing model ensures reliable and consistent supply of high-quality process liquids and buffers for biomanufacturing.
Related webinars
Discover how LCA enhances product development, fosters innovation, and builds customer trust.
This webinar covers current regulatory considerations, the role of nitrites, and necessary analytical controls, along with a case study on risk mitigation.
Webinar explores regulatory considerations, nitrites' role, analytical controls, and a drug manufacturer's risk mitigation strategy.
Learn how to managing endotoxins, including possible endotoxins contamination sources during manufacturing and strategies for endotoxin removal.