The Emprove® Program—Accelerate Risk Management and Meet Pharmaceutical Regulatory Requirements
Are you facing challenges with qualification documentation needed for risk assessment and regulatory approval?
As regulatory requirements are constantly evolving, navigating compliance can be daunting. The Emprove® Program accelerates your risk assessment by simplifying this process through on-demand, online access to comprehensive documentation and regulatory information for thousands of products.
With extensive technical, quality, and supply data at your fingertips in the Emprove® Suite—our 24/7 online repository—you can expedite supplier selection, material qualification, risk assessments, and compliance, ensuring a smoother path from development to approval.
Smarter risk management and regulatory readiness with the Emprove® Program
In an industry where qualifying new raw materials is complex and pharmaceutical regulatory requirements are constantly evolving, the Emprove® Program keeps you on track while prioritizing safety, quality, and sustainability. Benefit from:
Maintain compliance and streamline risk management with all required data conveniently provided in comprehensive dossiers.
Leverage reliable, up-to-date documentation for accelerated, risk-based decisions — easily accessible through our Emprove® Suite.
Simple installation, operation and integrity testing from pilot to full-scale manufacturing.
The Emprove® Program: Comprehensive documentation available at your fingertips
The Emprove® Program transcends traditional documentation; it serves as a comprehensive resource that provides regulatory, technical, and supply information tailored to the evolving pharmaceutical landscape. By spearheading innovation, proactively addressing emerging trends, and anticipating future regulatory requirements, we equip our customers with the insights necessary to rapidly assess risks and validate processes.
Benefit from easy access to reliable information across a broad product portfolio, streamlining your supplier selection, qualification and risk assessment efforts. This holistic approach helps accelerate your time to market while supporting your efforts in achieving regulatory compliance. Read on to learn more about the Emprove® Suite, Emprove® Dossiers, and our Emprove® Portfolio.
The Emprove® Suite: Your gateway to product dossiers
Register for Emprove® Suite, our 24/7 online repository, to gain unlimited, secure access to product dossiers along with enhanced search functionality, timely notifications of dossier revisions, and downloadable metrics and reports, enabling you to create custom reports to share within your organization—at no additional charge!
The Emprove® Dossiers: Easy access to comprehensive, reliable information
The Emprove® Dossier content is structured into a series of comprehensive dossiers, compiled in alignment with the ICH Common Technical Document (CTD) Chapter 3 format. The dossiers are designed to support all the steps in the raw material and component risk assessment and pharmaceutical regulatory compliance continuum including:
- Material qualification
- Supplier selection and qualification
- Process optimization
- Patient safety evaluation
- Supply chain transparency
Do you want to know what a dossier looks like? Download a free demo dossier.
The Emprove® Program now includes more than 500 raw materials, cell culture media products, and chromatography resins, along with 1,100 filtration products, and 450 single-use components—and is continuously expanding!
Frequently asked questions
What are the key challenges in pharmaceutical risk management?
The key challenges in pharmaceutical risk management include navigating complex regulatory requirements; ensuring the quality and consistency of raw materials, process components, and products; managing supplier relationships which includes access to reliable product information and supply chain transparency; as well as maintaining compliance throughout the product lifecycle. Changes in regulations or guidelines and the need for timely access to accurate information can complicate risk assessment and require constant revision of workflows and maintenance of documentation.
What is the importance of documentation in regulatory approval of pharmaceutical drug products?
Documentation is crucial in the registration process as it provides the evidence needed to demonstrate the drug product meets safety, efficacy, and quality standards which are required for regulatory approval. Comprehensive documentation helps regulatory agencies assess compliance with established guidelines, for example whether the excipients used in formulating the drug product meet IPEC PQG GMP standards. The documentation needs to be provided in a specific format, the ICH Common Technical Document (CTD) which is harmonized across regulatory authorities such as the EMA and FDA.
How can suppliers support qualification and risk assessment?
Suppliers can support qualification and risk assessment by providing detailed documentation, including quality and safety data, that demonstrates the reliability and safety of their products. Such data includes information on the manufacturing process and raw materials used, supply chain and original manufacturer information, and detailed product data such as elemental impurity information, nitrosamines risk assessment, extractables and leachables and much more. By maintaining open communication and providing expert support, as well as established change communication processes, suppliers can help reduce the effort for pharmaceutical manufacturers. Find out how our quality and regulatory experts can support you or access the relevant documentation directly through our Emprove® Suite.
What are the best practices for qualifying raw materials and process components in biopharmaceutical and pharmaceutical manufacturing?
Best practices for qualifying raw materials and process components include conducting thorough supplier evaluations, utilizing standardized testing protocols, maintaining comprehensive documentation, and implementing risk assessment methodologies. Additionally, ongoing monitoring and validation of materials throughout the manufacturing process are essential to ensure compliance and product quality. We provide extensive information for thousands of our products through our Emprove® Dossiers, backed by our risk management system and commitment to quality. Access the Emprove® Dossiers through our Emprove® Suite or learn more about our quality culture.
How can tailored documentation help streamline my risk assessment and regulatory compliance efforts?
If the information provided by the supplier is tailored to reflect current regulatory requirements and is provided in a format following the ICH Common Technical Document (CTD) modules required by regulatory authorities, this can significantly reduce the effort needed for compiling the documentation for the registration process. Our Emprove® Dossiers are set up in line with the CTD Chapter 3 format and are designed to support different steps in your risk assessment and regulatory compliance continuum. Hence, we provide reliable product information in four different dossier formats:
- Material Qualification Dossier to support you in qualifying individual products
- Quality Management Dossier to help you qualify us as a vendor
- Operational Excellence Dossier to streamline risk mitigation and process set-up
- Advanced Qualification Dossier to qualify and demonstrate patient safety of our custom single-use assemblies
What types of products are included in the Emprove® Program and how does this benefit my process?
The Emprove® Program now covers more than 500 raw materials and excipients across various categories designed to support processes from cell culture to final formulation, 1,100 filters and 450 single-use components for all process steps with dossiers including extractables and leachables data, as well as chromatography resins and cell culture media—and is continuously expanding. Our Emprove® Dossiers compile comprehensive and reliable technical, quality, and supply information, reducing your risk assessment, qualification and regulatory compliance efforts. What’s the best part? All our Emprove® Dossiers can be easily accessed on-demand and for free online in our Emprove® Suite.
How can I access the technical, quality, and supply documentation as it is provided as part of the Emprove® Program?
Our online repository Emprove® Suite provides easy, on-demand, secure online access to our Emprove® Dossiers. In addition, it offers enhanced search functionality, timely notifications of dossier updates, downloadable metrics and reports as well as the option to create custom reports. Learn more about the Emprove® Suite.
Related product resources
- Data sheet: Emprove® Advanced Qualification Dossier
Simplifying the qualification of Mobius® Custom Assemblies.
- Article: Successfully navigate the regulatory landscape for chemicals and single-use consumables
This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.
- 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: Reducing the need for animal testing for biological reactivity in polymer characterization
This page provides an overview of USP <87>, <88>, and <1031>, compares bioreactivity testing, and describes the transition of our organization towards in vitro test methods.
- Article: Best practices for qualifying single-use assemblies
Key aspects of single-use assembly qualification including quality by design (QbD), quality risk management (QRM) and operator handling and training.
- Article: Extractables and leachables risk assessment for single-use systems
Before adoption of single-use technologies in biomanufacturing, manufacturers must assess the risk to the drug product from potential leachables. This article highlights a general approach based on the United States Pharmacopeia (USP).
Related webinars
Explore strategies for particulate control, detection, and process improvement in single-use manufacturing.
Gain practical insights into EU GMP Annex 1 compliance and quality approaches for single-use systems.
Learn practical strategies for preventing, detecting, and managing particulate contamination in single-use processes.
Discover regulatory considerations, nitrite testing, and a case study on nitrosamine risk reduction.
