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.

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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 CTD chapter 3 quality (adapted for excipients)

• General information
• Manufacturer
• Characterization (incl. regulatory declarations:
  BSE/TSE, melamine, nitrosamine, etc.)
• Control of drug substance
• Reference standard
• Materials
• Container closure system
• Stability summary

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
• Product quality self-assessment**
• Audit report summary
• Stability data***

5.500 €

**Based on Rx-360 SAQ Module 3
*** Available for Emprove^® Essential and Emprove^® Expert products only, based on long-term stability studies according to ICH Q1A requirements.

Operational Excellence Dossier

Supports process optimization and safety risk assessment activities.

• Elemental impurities information
• Product quality report
• Analytical procedure
• Technically Unavoidable Particle Profile (if applicable)

3.500 €

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

	Emprove® Evolve	Emprove® Essential	Emprove® Expert	Emprove® API
Quality systems	ISO 9001 + GMP Elements*	IPEC-PQG GMP Guide and/or EXCiPACT™	IPEC-PQG GMP Guide and/or EXCiPACT™	ICH Q7
Pharmacopeia	No	✓	✓	✓
Quality agreement	✓	✓	✓	✓
Self-inspection	✓	✓	✓	✓
Change notification	✓	✓	✓	✓
Batch number explanation	✓	✓	✓	✓
Letter of access/authorization	Not applicable	Not applicable	Not applicable	✓

Supply Chain

	Emprove® Evolve	Emprove® Essential	Emprove® Expert	Emprove® API
Supply chain information (chain of custody)	✓	✓	✓	✓
Vendor audits	✓	✓	✓	✓
Original manufacturer	✓	✓	✓	✓

Manufacturing

	Emprove® Evolve	Emprove® Essential	Emprove® Expert	Emprove® API
Manufacturing flow chart	✓	✓	✓	Applicants part
Quality self-assessment	✓	✓	✓	✓
Product Quality Report*	✓	✓	✓	Internal review
Container closure system	✓	✓	✓	Applicants part
Long-term stability report**	No	✓	✓	Applicants part
*Based on Rx360 SAQ Module 3. **Based on long-term stability studies according to ICH Q1A requirements.

Certificates

	Emprove® Evolve	Emprove® Essential	Emprove® Expert	Emprove® API
TSE/BSE certificate	✓	✓	✓	✓
Allergen certificate	✓	✓	✓	✓
Aflatoxin certificate	✓	✓	✓	✓
Melamine certificate	✓	✓	✓	✓
GMO certificate	✓	✓	✓	✓
Halal/Kosher certificate	✓ if applicable	✓ if applicable	✓ if applicable	✓ if applicable

Specifications

	Emprove® Evolve	Emprove® Essential	Emprove® Expert	Emprove® API
Justification of specification	✓	✓	✓	Applicants part
Analytical methods	✓	✓	✓	Applicants part
Validation report open part	No	✓	✓	Applicants part
Residual solvents, residual catalyst/ elemental impurities	✓	✓	✓	✓
Low level endotoxins specified	Depending on product	—	✓	Depending on product
Low microbiological limits specified	Depending on product	—	✓	Depending on product

Emprove^® Suite: 24/7 online access to all our dossiers

Unlock all the benefits of the Emprove^® Chemicals portfolio by subscribing to our Emprove^® Suite. Available exclusively for subscribers, all dossiers of the entire Emprove^® portfolio can be accessed at your convenience.

• Subscriptions of one, two, or five years
• 24/7 online access
• Constantly updated
• Optimized searches

Related Product Resources

Webinar: New PDA/IPEC Technical Report on excipient risk assessment – insights for drug product manufacturers
Webinar: BioPhorum Raw Materials Risk Assessments
Webinar: The Emprove^® Program – an introduction focusing on the Emprove^® Suite and Emprove^® Chemicals content
Webinar: New developments of excipient regulations in China
Webinar: Nitrosamines - New Requirements to Evaluate Contamination Risks
White Paper: Identifying Appropriate-quality Raw Materials in an Evolving Regulatory Environment
Risk Mitigation Tool: Support for Biomanufacturing Processes
Brochure: Satisfy your regulatory requirements

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