|
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 | ✓ |
- The Emprove® Program
- Chemicals
- Filters & Single-use
- Chromatography
- Cell Culture Media
- Emprove® Suite Subscription
Quality
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 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 |