Regulatory
- Non-GMP: Manufactured utilizing GMP concepts and elements; ISO9001 or equivalent
- Supply chain transparency and control
- No defined industry standards or regulations
- Non-compendial, not for direct human use
- The Emprove® Program
- Chemicals
- Filters & Single-use
- Chromatography
- Cell Culture Media
- Emprove® Suite Subscription
Early stage manufacturing
The new Emprove® Evolve product line provides fit-for-purpose high-quality raw materials addressing applications in early stages of pharmaceutical and biopharmaceutical manufacturing such as:
- upstream processing
- early downstream processing
- clean-in-place
- early synthetic steps in small molecule drug manufacture
Why Emprove® Evolve?
Evolving regulations of raw materials
used during production process
These critical raw materials have no clearly defined regulatory standards or quality requirements but are coming more and more into regulatory focus.
The Emprove® Evolve product line supports your quality risk assessment with detailed documentation and supply chain transparency and control, helping you to meet developing regulatory requirements for critical raw materials.
How Emprove® Evolve fits into existing categories
The next step in advancing the Emprove® portfolio
The Emprove® Evolve product line takes the next step in advancing the Emprove® portfolio. This new range of products fills the gap between lab-grade and GMP-compliant raw and starting materials. This new category gives you easy access to Emprove® quality, matching the demands of the earliest stages of your manufacturing process by lending GMP elements to non-GMP material.
The high level of characterization and documentation allows you to take more control of the inputs to your manufacturing process, by using high-quality raw materials which are a product of controlled manufacturing and release processes.
Emprove® Evolve
Product line provides detailed and transparent supply chain information and documentation to support risk assessments for critical raw materials used in manufacturing processes.
Emprove® Essential
Product line is designed for moderate risk levels. Best-in-class regulatory support is combined with our high quality standards.
Emprove® Expert
Product line addresses higher risk applications, where the lowest microbiological and endotoxin levels are of utmost importance. These products are documented as being manufactured with low microbio logical and endotoxin levels.
Emprove® API
Product line provides the right quality and regulatory documentation required for active pharmaceutical ingredients. All the products in this line are manufactured in Europe and comply with ICH Q7 requirements.
Emprove® Evolve
Emprove® Essential & Emprove® Expert
Regulatory
- GMP: IPEC-PQG GMP Guide and/or EXCiPACT™ Certification Standard plus elements of ICH Q7
- Defined regulations and GMP standards
- Compendial compliance; intended as suitable for human use
Regulatory Example Uses/Applications
- Process chemicals & clean-in-place
- Upstream, early downstream, early synthetic steps
Regulatory Example Uses/Applications
- Higher risk applications
- Close to final drug product & patient
- Formulation, late downstream & purification
Product Shelf-life/Stability
- The shelf-life is determined by product history data and current scientific knowledge and is supported by periodic testing of multiple batches
- Summary statement in Emprove® Dossier
Product Shelf-life/Stability
- Long-term stability studies according to ICH Q1A requirements
- Detailed stability study data in Emprove® Dossier
Supplier Qualification
- High
- On-site audit preferred; exceptions possible under certain conditions
- Paper assessment mandatory
- Change agreement
Supplier Qualification
- High
- On-site audit mandatory
- Quality agreement
- Change agreement
Change Control
- High
Change Control
- High