Our Emprove® Chemicals portfolio contains over 400 pharmaceutical raw materials. To address different levels of risk, and to simplify and streamline the selection process, the portfolio is divided into four categories:
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Fills the gap between lab-grade and GMP compliant raw and starting materials. This product line provides detailed and transparent supply chain information and documentation to support risk assessments for critical raw materials used in manufacturing processes.
Designed for moderate risk applications, Emprove® Essential products offer compliance to IPEC-PQG GMP Guide and/or EXCiPACT™ Certification Standard, supply chain transparency and regulatory support designed to assist drug manufacturers' formalized risk assessments. They are produced according to controlled manufacturing processes. Critical parameters such as elemental impurities and residual solvents are characterized by using validated analytical techniques.
Addresses 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 goes even further: The GMP (IPEC-PQG and/or EXCiPACT™) manufacturing processes are designed to yield products with specified low microbiological and endotoxin levels, thus supporting the overall risk mitigation strategy.
Manufactured in Europe to meet the quality and regulatory requirements of active pharmaceutical ingredients, according to ICH Q7 GMP. In order to support final drug product compliance with international standards, our Regulatory Management team offers dedicated support with access to extensive documentation including DMFs, CEP and ASMF.
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.
For Emprove® API products we offer LoA (letter of authorization, letter of access, CEP access), granting the right to incorporate the DMF, ASMF or CEP dossier by reference in the drug product application. Elemental Impurity Reports can also be obtained as part of the Emprove® Suite.
| Emprove® Chemical Dossiers | ||||
|---|---|---|---|---|
| Material Qualification | Quality Management | Operational Excellence | DMF, ASMF, CEP | |
| Emprove® Evolve | ✓ | ✓ | ✓ | |
| Emprove® Essential | ✓ | ✓ | ✓ | |
| Emprove® Expert | ✓ | ✓ | ✓ | |
| Emprove® API | ✓ | |||
Unlock all the benefits of Emprove® Chemical Portfolios with the Emprove® Suite Subscription.
SubscribeEmprove® Dossiers are available exclusively through the Emprove® Suite Subscription.