Emprove® Program > Emprove® Chemicals > Emprove® Chemical Quality and Service Catalog
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Quality and Service Catalog for Emprove® Raw and Starting Materials

Quality, Supply Chain, Manufacturing, Certificates and Specifications

 

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 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