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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

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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

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Supply chain information (chain of custody) ✓ ✓ ✓ ✓
Vendor audits ✓ ✓ ✓ ✓
Original manufacturer ✓ ✓ ✓ ✓

Manufacturing

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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

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TSE/BSE certificate ✓ ✓ ✓ ✓
Allergen certificate ✓ ✓ ✓ ✓
Aflatoxin certificate ✓ ✓ ✓ ✓
Melamine certificate ✓ ✓ ✓ ✓
GMO certificate ✓ ✓ ✓ ✓
Halal/Kosher certificate ✓
if applicable		 ✓
if applicable		 ✓
if applicable		 ✓
if applicable

Specifications

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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